Diagnosis and Staging of Neuroendocrine Tumors (NETs) Utilizing 68Ga-DOTATOC PET/CT Scan

• Sponsor: Charito Love (Other)
• Overall Status: Completed
• CT.gov ID: NCT03136328
• Collaborator: NCM USA (Other)
• Enrollment: 11
• Arm: 1
• Actual Duration (Months): 9.5

Study Details

Study Description

Brief Summary

The primary goal of the analysis is to estimate the diagnostic accuracy of Gallium 68 (68Ga) -DOTATOC PET/CT for detecting neuroendocrine tumors (NETs) compared to conventional imaging techniques such as Magnetic Resonance Imaging (MRI) and Computerized Tomography (CT). Participants with histologically and/or clinically confirmed and/or suspected NET will be enrolled.

Condition or Disease	Intervention/Treatment	Phase
Neuroendocrine Tumors	Drug: 68Ga-DOTATOC	Phase 3

Detailed Description

This is a prospective, Phase 2, single center study of participants with Neuroendocrine Tumors (NETs). Study participants will receive 68Ga-DOTATOC. DOTATOC is a somatostatin analogue that localizes on the somatostatin receptors expressed by NETs and is attached to a radioactive material called Gallium 68. Participants will undergo a PET/CT imaging study to investigate 68Ga-DOTATOC's suitability as a positron emission tomography (PET) imaging agent for NETs. The radiation (imaging) dose will be 111-185 megabecquerel (MBq) (3 - 5 mCi) ± 25%. All doses after labeling will be presented in buffered solution for intravenous injection. Imaging will start 90 ±30 minutes after injection.

Sensitivity and specificity of this imaging technique will be compared with those of conventional imaging modality including CT, MRI and In-111 Octreoscan performed within 6-12 months before or after PET/CT.

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Diagnosis and Staging of Neuroendocrine Tumors (NETs) Utilizing 68Ga-DOTATOC PET/CT Scan
• Actual Study Start Date: May 16, 2016
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 68Ga-DOTATOC PET/CT Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study.	Drug: 68Ga-DOTATOC; The intervention is to administer 68Ga-DOTATOC PET/CT for detecting NET.; Other Names: Diagnostic test

Outcome Measures

Primary Outcome Measures

1. Sensitivity to Correctly Diagnose NET [During imaging process ( approximately 120 minutes)]

   Sensitivity to detect NET will be assessed and compared with conventional imaging modality. Sensitivity is the ability of an agent to indicate the presence and location of NET. The ability of 68Ga-DOTATOC to localize more effectively to somatostatin receptors and the exquisite spatial resolution of PET/CT should make easier detection of primary and metastatic neuroendocrine tumors and allow better measurement of tumor burden. Sensitivity is the percentage of accurately diagnosed NET cases. All participants underwent conventional imaging with either Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) as standard care prior to 68Ga-DOTATOC imaging.

Secondary Outcome Measures

1. Specificity to Detect True Negative [During imaging process ( approximately 120 minutes)]

   A tumor is an abnormal growth of cells which can be malignant or not. NET tumors secrete hormones that will disrupt the normal ecology of the body. 68Ga-DOTATOC is extremely sensitive and specific to the receptors expressed by NET. These attributes are unique to 68Ga-DOTATOC and makes it the only imagining technique that can determine whether or not lesions detected by conventional imaging is due to NET involvement. 68Ga-DOTATOC is able to exclude disease involvement in lesions detected on CT/MRI; this ability to exclude disease involvement is called Specificity. The reported values indicate the specificity of 68Ga-DOTATOC, which is the percentage of tumors detected by conventional imagining that 68Ga-DOTATOC correctly determined were not due to NET involvement (i.e. identifying true negative for NET).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Signed informed consent.

• Patients of either gender, aged ≥18 years.

• Karnofsky status ≥60.

• Life expectancy of at least 12 weeks.

• Histologically and/or clinically confirmed and/or suspicious of NET.

• A diagnostic CT or MRI of the tumour region or suspected area within the previous 12 weeks prior to dosing day is available.

• Somatostatin-analogue scintigraphy scan with result (positive or negative) within the last 12 weeks.

• Recent Blood test results up to 4-6 weeks as follows:

1. White Blood Cell (WBC): >2*109/L

2. Haemoglobin: >8.0g/Dl

3. Platelets: >50x109/L

4. Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Alkaline phosphatase (AP) each less than, or equal to, 5 times its Upper Limit of Normal (ULN)

5. Bilirubin less than, or equal to, three times its ULN

• Serum creatinine: within normal range or <120μmol/L for patients aged 60 years or older.

• Negative pregnancy test in women capable of child-bearing.

Exclusion Criteria:

• Known hypersensitivity to Gallium 68, DOTATOC or to any of the excipients of 68Ga-DOTATOC.

• Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (Long Acting Release) (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a patient is on Sandostatin® LAR a wash-out phase of 28 days is required before the injection of the study drug.

• Pregnant or breast-feeding women.

• Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Charito Love
• NCM USA

Investigators

• Principal Investigator: Charito Love, MD, Montefiore Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 20, 2016

More Information

Publications

None provided.

• Responsible Party: Charito Love, Associate Professor of Radiology, Montefiore Medical Center
• ClinicalTrials.gov Identifier: NCT03136328
• Other Study ID Numbers: 15-06-274
• First Posted: May 2, 2017
• Last Update Posted: Mar 7, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neuroendocrine Tumors; Edotreotide

Study Results

Participant Flow

Recruitment Details	Participants were recruited at Montefiore Medical Center which has medical specializing in the diagnosis and treatment of NETs. Eligible participants were those referred by their physicians for PET (Positron Emission Tomography) or CT imaging due to suspected or confirmed NETs.

Arm/Group Title	68Ga-DOTATOC PET/CT
Arm/Group Description	Study participants will receive Gallium 68 (68Ga)-DOTATOC and undergo a PET/CT imaging study.
Period Title: Overall Study
STARTED	11
COMPLETED	11
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	68Ga-DOTATOC PET/CT
Arm/Group Description	Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study to measure its ability to detect primary NET and any metastasis.
Overall Participants	11
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.3 (8.5)
Sex: Female, Male (Count of Participants)
Female	9 81.8%
Male	2 18.2%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
United States	11 100%

Outcome Measures

1. Primary Outcome

Title	Sensitivity to Correctly Diagnose NET
Description	Sensitivity to detect NET will be assessed and compared with conventional imaging modality. Sensitivity is the ability of an agent to indicate the presence and location of NET. The ability of 68Ga-DOTATOC to localize more effectively to somatostatin receptors and the exquisite spatial resolution of PET/CT should make easier detection of primary and metastatic neuroendocrine tumors and allow better measurement of tumor burden. Sensitivity is the percentage of accurately diagnosed NET cases. All participants underwent conventional imaging with either Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) as standard care prior to 68Ga-DOTATOC imaging.
Time Frame	During imaging process ( approximately 120 minutes)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	68Ga-DOTATOC PET/CT	Conventional Imaging
Arm/Group Description	Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study.	All participants underwent conventional imaging with either Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) or In-111 Octreoscan as standard care prior to 68Ga-DOTATOC imaging.
Measure Participants	11	11
Primary lesions	75	75
Liver metastases	100	75
Lymph node metastasis	100	40
Bone metastasis	100	50

2. Secondary Outcome

Title	Specificity to Detect True Negative
Description	A tumor is an abnormal growth of cells which can be malignant or not. NET tumors secrete hormones that will disrupt the normal ecology of the body. 68Ga-DOTATOC is extremely sensitive and specific to the receptors expressed by NET. These attributes are unique to 68Ga-DOTATOC and makes it the only imagining technique that can determine whether or not lesions detected by conventional imaging is due to NET involvement. 68Ga-DOTATOC is able to exclude disease involvement in lesions detected on CT/MRI; this ability to exclude disease involvement is called Specificity. The reported values indicate the specificity of 68Ga-DOTATOC, which is the percentage of tumors detected by conventional imagining that 68Ga-DOTATOC correctly determined were not due to NET involvement (i.e. identifying true negative for NET).
Time Frame	During imaging process ( approximately 120 minutes)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	68Ga-DOTATOC PET/CT
Arm/Group Description	Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study.
Measure Participants	11
Primary lesions	100
Liver metastases	100

Adverse Events

Time Frame	The somatostatin analogue being administered is a short acting agent that, if it caused an adverse effect, would be seen within a few minutes after administration. Participants were monitored for one hour after injection. Participants were systematically assessed and questioned regarding changes in sensation or appearance of new symptom.
Arm/Group Title	68Ga-DOTATOC PET/CT
Arm/Group Description	Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study.
All Cause Mortality
	68Ga-DOTATOC PET/CT
	Affected / at Risk (%)	# Events
Total	0/11 (0%)
Serious Adverse Events
	68Ga-DOTATOC PET/CT
	Affected / at Risk (%)	# Events
Total	0/11 (0%)
Other (Not Including Serious) Adverse Events
	68Ga-DOTATOC PET/CT
	Affected / at Risk (%)	# Events
Total	0/11 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.