A Proof-of-concept Study to Assess the Ability of [18F]AH-111585 PET Imaging to Detect Tumours and Angiogenesis

• Sponsor: GE Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00565721
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Arm: 1
• Duration (Months): 58
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

This proof-of-concept study is designed to assess the ability of [18F]AH-111585 PET imaging to detect tumors and angiogenesis. Up to 30 evaluable subjects are planned to be included at up to 2 study centers in the US. Subjects are considered evaluable if they undergo administration of AH-111585 (18F) Injection, dynamic and static PET imaging, and tumor tissue acquisition. The targeted population is adult subjects at initial diagnosis or recurrence with tumors ≥2.5 cm in diameter who are scheduled to undergo resection or biopsy of the tumor as a result of routine clinical treatment. The tumors must belong to one of the following 5 types:

• High-grade glioma, including glioblastoma multiforme, anaplastic astrocytoma, and anaplastic oligodendroglioma

• Lung cancer, including small cell lung cancer and non-small cell lung cancer

• Head and neck (H&N) tumors, including laryngeal squamous cell carcinoma, well-differentiated thyroid and oral cavity carcinoma

• Sarcoma

• Melanoma

Safety will be assessed from the rates of adverse events, changes in vital signs, changes in electrocardiogram (ECG) parameters, changes in physical examination findings, and changes in clinical laboratory findings.

Efficacy will be assessed as the correlations between parameters derived from the PET images and the reference standards. The reference standards will be immunohistology for αvβ3 integrins and other biomarkers specific for oncology and angiogenesis and from the standard of care imaging.

Measures obtained from optional DCE-CT imaging may also be used to compare the uptake and retention of [18F]AH-111585 in tumors obtained from the dynamic PET to assess functional status of the vascular system of the tumor.

Condition or Disease	Intervention/Treatment	Phase
High-grade Glioma; Lung Cancer; Head & Neck Cancer; Sarcoma; Melanoma	Drug: Fluciclatide Injection - (AH111585 (F18))	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: A Phase 2, Open-label, Proof-of-concept Study to Assess the Ability to Detect Tumours and Angiogenesis Via the Expression of ανβ3/5 Integrin Receptors by [18F]AH-111585 PET Imaging
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fluciclatide Injection - (AH111585 (F18)) Using of the drug product named, AH111585 (F18) Injection. It's generic chemical name is Fluciclatide.	Drug: Fluciclatide Injection - (AH111585 (F18)); 18F labelled Cyclic RGD peptide PET agent for injection.; Other Names: Fluciclatide

Outcome Measures

Primary Outcome Measures

1. Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 (Beta-3 Integrin) Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak and αvβ3 Optical Density) [Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.]

   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively. 0.22 and 0.24 equals a weak positive correlation and 0.16 and 0.18 equals a negligible correlation. Three (3) of the 22 subjects did not have any αvβ3 integrin results. Ki-inp-Patlak is a graphical analysis technique based on the compartment model that uses linear regression to identify and analyze pharmacokinetics of tracers involving irreversible uptake.

2. Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ3 Optical Density) [Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.]

   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively. The Logan plot is the counterpart of the Patlak plot for reversible radiotracers.

3. Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 (Beta-3 Integrin) Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ3 Optical Density) [Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.]

   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively. SUVw_55 is the standard uptake value at 55 minutes post-injection, normalized to weight.

4. Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 (Beta-3 Integrin) Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ3 Optical Density) [Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.]

   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively. Twelve (12) of the 22 subjects had renal cell carcinoma (RCC) the remaining subjects did not have RCC. SUVR_55_blood is the standard uptake value ratio (tumor-to-blood) at 55 minutes post-injection.

5. Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak and αvβ3 Optical Density) [Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.]

   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.

6. Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ3 Optical Density) [Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.]

   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.

7. Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ3 Optical Density) [Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.]

   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.

8. Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ3 Optical Density) [Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.]

   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.

Secondary Outcome Measures

1. Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak αvβ5 Optical Density) [Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.]

   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively. 0.60 to 0.44 equals a moderately positive correlation and 0.33 to 0.37 equals a weak positive correlation. Two (2) of the 22 subjects did not have any αvβ5 integrin results.

2. Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ5 Optical Density) [Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.]

   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.

3. Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ5 Optical Density) [Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.]

   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.

4. Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ5 Optical Density) [Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.]

   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.

5. Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak and αvβ5 Optical Density) [Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.]

   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.

6. Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ5 Optical Density) [Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.]

   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.

7. Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ5 Optical Density) [Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.]

   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.

8. Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ5 Optical Density) [Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.]

   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Selection of Subjects: The targeted subject population is adult subjects at initial diagnosis or recurrence with tumours ≥2.5 cm in diameter who are scheduled to undergo resection or biopsy of the tumour as a result of routine clinical treatment.

General Inclusion Criteria for all Subjects:

• The subject is ≥18 years old.

• The subject has been diagnostically imaged and is suspected of having a primary or metastatic tumour lesion ≥2.5 cm of one of the following types: high-grade glioma, including glioblastoma multiforme, anaplastic astrocytoma, and anaplastic oligodendroglioma; lung cancer, including small cell lung cancer and non-small cell lung cancer; H&N tumours, including laryngeal squamous cell carcinoma, and well-differentiated thyroid and oral cavity carcinoma; sarcoma; and melanoma.

• The subject is scheduled to undergo resection or biopsy of the ≥2.5 cm target tumour as a result of routine clinical treatment.

• The subject is scheduled to undergo or has received standard of care diagnostic imaging work-up (following the study centre's routine procedures), e.g. CT with or without contrast, MRI with or without contrast, bone scintigraphy, X-ray, or FDG-PET.

• Female subjects need to be either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post menopausal (cessation of menses for more than 1 year), or if of childbearing potential the results of a serum pregnancy test performed within 24 hours must be negative and with the result known before administration of AH-111585 (18F) Injection. Female subjects of reproductive potential should also employ an effective method of birth control. Barrier contraceptives must be used throughout the study in both sexes.

• The subject is able and willing to comply with study procedures, and signed and dated informed consent is obtained.

• The subject has a blood urea nitrogen value and serum creatinine value of ≤1.5 of the upper normal limit.

• The subject has a platelet count of >75,000 x 10^6/L.

• The subject has a haemoglobin value of >9 g/dL.

• The subject has a prothrombin time and an activated partial thromboplastin time and within normal limits.

• The subject has a clinically acceptable (as judged by the investigator) physical examination at screening and is capable of self-care, i.e. Eastern Cooperative Oncology Group performance status is 0 to 2, such that the subject has a high chance to complete the study.

• The subject has not received any anti-angiogenic agents (e.g. bevacizumab, sorafenib, sunitinib) within 10 days prior to PET imaging.

• The subject has had no open wounds within 10 days prior to study entry.

• The chosen target tumour is not within the liver.

Inclusion Criteria Specific for Subjects with High-grade Glioma:

• The subject is suspected of having supratentorial malignant primary glioma (by biopsy or presenting MRI characteristics as determined by the subject's clinician) requiring further surgical resection as part of the recommended treatment plan for their newly diagnosed disease. These gliomas include glioblastoma multiforme, anaplastic astrocytoma, and anaplastic oligodendroglioma.

• The subject has undergone recent biopsy of newly diagnosed high-grade glioma, has recovered from the effects of surgical biopsy, and baseline on-study MRI/CT is performed within 14 days of entry into the study.

Exclusion Criteria:

• The subject is lactating.

• The subject is being treated with heparin or coumadin.

• The subject has received another investigational medicinal product (IMP) within 14 days before, or will receive an IMP within 1 week after administration of AH-111585 (18F) Injection.

• The subject was previously included in this study.

• The subject experienced substantial changes in their medical status before all essential study procedures (including all imaging procedures and surgical excision or biopsy) are performed.

• The subject has any contraindication to any of the study procedures, products used or its constituents (e.g. X-ray contrast media).

• The subject has known hyper- or hypo-coagulation syndromes. Such coagulopathies include but are not limited to Von Willebrand disease, Protein C deficiency, Protein S deficiency, Hemophilia A/B/C, Factor-V Leiden, and Bernard-Soulier syndrome.

• The subject is unable to lie down for 125 minutes.

• The subject suffers from claustrophobia.

• The subject has known diagnosis of human immunodeficiency virus (HIV) infection.

• The subject has known diagnosis of hepatitis B or C infection.

• The subject has known diagnosis of mental incapacitation and it affects their ability to consent.

• The subject has been diagnosed with a primary or metastatic tumour lesion <2.5 cm.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GE Healthcare Office	Princeton	New Jersey	United States	08540

Sponsors and Collaborators

• GE Healthcare

Investigators

• Study Director: Jeffrey Winick, Ph.D., GE Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GE Healthcare
• ClinicalTrials.gov Identifier: NCT00565721
• Other Study ID Numbers: GE-135-003; NCT00923767
• First Posted: Nov 30, 2007
• Last Update Posted: Aug 18, 2014
• Last Verified: Aug 1, 2014

• Keywords provided by GE Healthcare: Static PET imaging; Dynamic PET imaging; Angiogenesis; αvβ3 integrins; oncology imaging
• Additional relevant MeSH terms: Melanoma; Sarcoma; Head and Neck Neoplasms

Study Results

Participant Flow

Recruitment Details	A total of 33 subjects enrolled in this study. 16 subjects completed the study and 17 subjects did not.
Pre-assignment Detail	33 subjects enrolled,16 subjects completed and 17 did not complete. The reasons why 17 subjects that did not complete the study: 2 subjects failed screening, 6 subjects were lost to followup, 1 subject the procedure had technical problems, 2 subjects discontinued due to Physician decision, and 6 subjects had other reasons for not completing.

Arm/Group Title	Fluciclatide Injection
Arm/Group Description	The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)).
Period Title: Overall Study
STARTED	33
COMPLETED	16
NOT COMPLETED	17

Baseline Characteristics

Arm/Group Title	Safety With Fluciclatide Injection
Arm/Group Description	The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)).
Overall Participants	25
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.4 (10.09)
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	25 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	16 64%
Male	9 36%
Region of Enrollment (participants) [Number]
United States	24 96%
United Kingdom	1 4%

Outcome Measures

1. Primary Outcome

Title	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 (Beta-3 Integrin) Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak and αvβ3 Optical Density)
Description	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively. 0.22 and 0.24 equals a weak positive correlation and 0.16 and 0.18 equals a negligible correlation. Three (3) of the 22 subjects did not have any αvβ3 integrin results. Ki-inp-Patlak is a graphical analysis technique based on the compartment model that uses linear regression to identify and analyze pharmacokinetics of tracers involving irreversible uptake.
Time Frame	Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.

Outcome Measure Data

Analysis Population Description

This Outcome Measure was assessed among the Full Analysis Set (FAS), 3 of the 22 Subjects did not have any αvβ3 integrin results.

Arm/Group Title	Correlation Between Ki_inp-Patlak and αvβ3 Optical Density
Arm/Group Description	Correlation between Imaging parameters. The selected imaging parameters that reflected (18F) Fluciclatide tracer uptake and retention.
Measure Participants	19
Number (95% Confidence Interval) [Correlation coefficient]	0.22

2. Primary Outcome

Title	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ3 Optical Density)
Description	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively. The Logan plot is the counterpart of the Patlak plot for reversible radiotracers.
Time Frame	Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.

Outcome Measure Data

Analysis Population Description

This Outcome Measure was assessed among the Full Analysis Set (FAS), 3 of the 22 Subjects did not have any αvβ3 integrin results.

Arm/Group Title	Correlation Between VT_inp-Logan and αvβ3 Optical Density
Arm/Group Description	Correlation between Imaging parameters. The selected imaging parameters that reflected (18F) Fluciclatide tracer uptake and retention.
Measure Participants	19
Number (95% Confidence Interval) [Correlation coefficient]	0.24

3. Secondary Outcome

Title	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak αvβ5 Optical Density)
Description	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively. 0.60 to 0.44 equals a moderately positive correlation and 0.33 to 0.37 equals a weak positive correlation. Two (2) of the 22 subjects did not have any αvβ5 integrin results.
Time Frame	Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.

Outcome Measure Data

Analysis Population Description

This Outcome Measure was assessed among the Full Analysis Set (FAS), 2 of the 22 Subjects did not have any αvβ5 integrin results.

Arm/Group Title	Correlation Between Ki_inp-Patlak αvβ5 Optical Density
Arm/Group Description	The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)). Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors for the Full Analysis Set (FAS) subjects.
Measure Participants	20
Number (95% Confidence Interval) [Correlation coefficient]	0.60

4. Secondary Outcome

Title	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ5 Optical Density)
Description	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.
Time Frame	Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.

Outcome Measure Data

Analysis Population Description

This Outcome Measure was assessed among the Full Analysis Set (FAS), 2 of the 22 Subjects did not have any αvβ5 integrin results.

Arm/Group Title	Correlation Between VT_inp-Logan and αvβ5 Optical Density
Arm/Group Description	The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)). Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
Measure Participants	20
Number (95% Confidence Interval) [Correlation coefficient]	0.44

5. Primary Outcome

Title	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 (Beta-3 Integrin) Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ3 Optical Density)
Description	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively. SUVw_55 is the standard uptake value at 55 minutes post-injection, normalized to weight.
Time Frame	Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.

Outcome Measure Data

Analysis Population Description

This Outcome Measure was assessed among the Full Analysis Set (FAS), 3 of the 22 Subjects did not have any αvβ3 integrin results.

Arm/Group Title	Correlation Between SUVw_55 and αvβ3 Optical Density
Arm/Group Description	Correlation between Imaging parameters. The selected imaging parameters that reflected (18F) Fluciclatide tracer uptake and retention.
Measure Participants	19
Number (95% Confidence Interval) [Correlation coefficient]	0.16

6. Primary Outcome

Title	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 (Beta-3 Integrin) Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ3 Optical Density)
Description	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively. Twelve (12) of the 22 subjects had renal cell carcinoma (RCC) the remaining subjects did not have RCC. SUVR_55_blood is the standard uptake value ratio (tumor-to-blood) at 55 minutes post-injection.
Time Frame	Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.

Outcome Measure Data

Analysis Population Description

This Outcome Measure was assessed among the Full Analysis Set (FAS), 3 of the 22 Subjects did not have any αvβ3 integrin results.

Arm/Group Title	Correlation Between SUVR_55_blood and αvβ3 Optical Density
Arm/Group Description	Correlation between Imaging parameters. The selected imaging parameters that reflected (18F) Fluciclatide tracer uptake and retention.
Measure Participants	19
Number (95% Confidence Interval) [Correlation coefficient]	0.18

7. Primary Outcome

Title	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak and αvβ3 Optical Density)
Description	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
Time Frame	Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.

Outcome Measure Data

Analysis Population Description

This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).

Arm/Group Title	Correlation Between Ki_inp-Patlak and αvβ3 Optical Density
Arm/Group Description	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
Measure Participants	12
Number (95% Confidence Interval) [Correlation coefficient]	0.49

8. Primary Outcome

Title	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ3 Optical Density)
Description	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
Time Frame	Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.

Outcome Measure Data

Analysis Population Description

This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).

Arm/Group Title	Correlation Between VT_inp-Logan and αvβ3 Optical Density
Arm/Group Description	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
Measure Participants	12
Number (95% Confidence Interval) [Correlation coefficient]	0.56

9. Primary Outcome

Title	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ3 Optical Density)
Description	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
Time Frame	Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.

Outcome Measure Data

Analysis Population Description

This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).

Arm/Group Title	Correlation Between SUVw_55 and αvβ3 Optical Density
Arm/Group Description	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
Measure Participants	12
Number (95% Confidence Interval) [Correlation coefficient]	0.49

10. Primary Outcome

Title	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ3 Optical Density)
Description	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
Time Frame	Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.

Outcome Measure Data

Analysis Population Description

This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).

Arm/Group Title	Correlation Between SUVR_55_blood and αvβ3 Optical Density
Arm/Group Description	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
Measure Participants	12
Number (95% Confidence Interval) [Correlation coefficient]	0.44

11. Secondary Outcome

Title	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ5 Optical Density)
Description	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.
Time Frame	Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.

Outcome Measure Data

Analysis Population Description

This Outcome Measure was assessed among the Full Analysis Set (FAS), 2 of the 22 Subjects did not have any αvβ5 integrin results.

Arm/Group Title	Correlation Between SUVw_55 and αvβ5 Optical Density
Arm/Group Description	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.
Measure Participants	20
Number (95% Confidence Interval) [Correlation coefficient]	0.33

12. Secondary Outcome

Title	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ5 Optical Density)
Description	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.
Time Frame	Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.

Outcome Measure Data

Analysis Population Description

This Outcome Measure was assessed among the Full Analysis Set (FAS), 2 of the 22 Subjects did not have any αvβ5 integrin results.

Arm/Group Title	Correlation Between SUVR_55_blood and αvβ5 Optical Density
Arm/Group Description	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.
Measure Participants	20
Number (95% Confidence Interval) [Correlation coefficient]	0.37

13. Secondary Outcome

Title	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak and αvβ5 Optical Density)
Description	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
Time Frame	Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.

Outcome Measure Data

Analysis Population Description

This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).

Arm/Group Title	Correlation Between Ki_inp-Patlak and αvβ5 Optical Density
Arm/Group Description	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
Measure Participants	12
Number (95% Confidence Interval) [Correlation coefficient]	0.90

14. Secondary Outcome

Title	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ5 Optical Density)
Description	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
Time Frame	Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.

Outcome Measure Data

Analysis Population Description

This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).

Arm/Group Title	Correlation Between VT_inp-Logan and αvβ5 Optical Density
Arm/Group Description	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
Measure Participants	12
Number (95% Confidence Interval) [Correlation coefficient]	0.78

15. Secondary Outcome

Title	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ5 Optical Density)
Description	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
Time Frame	Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.

Outcome Measure Data

Analysis Population Description

This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).

Arm/Group Title	Correlation Between SUVw_55 and αvβ5 Optical Density
Arm/Group Description	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
Measure Participants	12
Number (95% Confidence Interval) [Correlation coefficient]	0.57

16. Secondary Outcome

Title	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ5 Optical Density)
Description	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
Time Frame	Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.

Outcome Measure Data

Analysis Population Description

This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).

Arm/Group Title	Correlation Between SUVR_55_blood and αvβ5 Optical Density
Arm/Group Description	Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
Measure Participants	12
Number (95% Confidence Interval) [Correlation coefficient]	0.74

Adverse Events

Time Frame	Up to 6 weeks post administration of Fluciclatide (GE-135) (18F) Injection at 10 mCi [370 megabecquerels (MBq)].
Arm/Group Title	Fluciclatide Injection
Arm/Group Description	The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)).
All Cause Mortality
	Fluciclatide Injection
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Fluciclatide Injection
	Affected / at Risk (%)	# Events
Total	5/25 (20%)
Blood and lymphatic system disorders
Anemia	1/25 (4%)	1
Idiopathic Thrombocytopenic Purpura (ITP)	1/25 (4%)	1
Injury, poisoning and procedural complications
Renal Injury	1/25 (4%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma Multiforme (GBM)	1/25 (4%)	1
Respiratory, thoracic and mediastinal disorders
Pneumothorax	1/25 (4%)	1
Skin and subcutaneous tissue disorders
Subcutaneous Emphysema	1/25 (4%)	1
Other (Not Including Serious) Adverse Events
	Fluciclatide Injection
	Affected / at Risk (%)	# Events
Total	13/25 (52%)
Gastrointestinal disorders
Gastrointestinal Disorders	3/25 (12%)	3
General disorders
General disorders and administration site conditions	5/25 (20%)	6
Infections and infestations
Infections and Infestations	3/25 (12%)	3
Investigations
Investigations	3/25 (12%)	4
Respiratory, thoracic and mediastinal disorders
Respiratory	2/25 (8%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.