GA-68 DOTA-TOC of Somatostatin Positive Malignancies

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02177773
• Collaborator: Peterson Family Foundation (Other)
• Enrollment: 300
• Location: 1
• Arm: 1
• Actual Duration (Months): 37.5
• Patients Per Site Per Month: 8

Study Details

Study Description

Brief Summary

This phase I/II trial studies how well gallium Ga 68-DOTA-TOC positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) works in imaging patients with somatostatin receptor positive tumors. Gallium Ga 68-DOTA-TOC binds to somatostatin receptor positive tumors and can be seen using a PET scan. A PET scan uses a special camera to detect energy given off from gallium Ga 68-DOTA-TOC, to make detailed pictures of areas where material accumulates in the body. Diagnostic procedures, such as gallium Ga 68-DOTA-TOC PET/CT or PET/MRI, may help find and diagnose somatostatin receptor positive tumors and help plan the best treatment.

Condition or Disease	Intervention/Treatment	Phase
Neuroendocrine Tumor; Paraganglioma; Carcinoid Tumors; Neuroblastoma	Procedure: Computed Tomography (CT); Drug: Gallium Ga 68-Edotreotide; Procedure: Magnetic Resonance Imaging (MRI); Procedure: Positron Emission Tomography (PET)	Phase 1/Phase 2

Detailed Description

PRIMARY OBJECTIVES:

1. To determine if gallium Ga 68-DOTA-TOC (gallium-68 labeled DOTA-TOC) results in the delineation of more lesions than with conventional imaging.

SECONDARY OBJECTIVES:

1. To determine if the incorporation of gallium (Ga)-68 DOTA-TOC PET/CT into the management decision making process results in a change in stage of the patient.

OUTLINE:

Patients receive gallium Ga 68-DOTA-TOC intravenously (IV) over 1-2 minutes. Within 55-70 minutes, patients then undergo a PET/CT scan over 30-40 minutes or a PET/MRI scan over 50 minutes.

After completion of study, patients are followed up for 2 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 300 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Evaluation of Gallium-68 DOTA-TOC Imaging of Somatostatin Receptor Positive Malignancies
• Actual Study Start Date: Jun 23, 2014
• Actual Primary Completion Date: Aug 7, 2017
• Actual Study Completion Date: Aug 7, 2017

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Ga-68 DOTA-TOC PET/CT Patients receive Gallium Ga 68-DOTA-TOC IV over 1-2 minutes. Within 55-70 minutes, patients then undergo either a PET/CT scan lasting 30-40 minutes or a PET/MRI scan lasting 50 minutes.

Procedure: Computed Tomography (CT); Undergo Gallium Ga 68-DOTA-TOC PET/CT; Other Names: CAT CAT Scan Computed Tomography Computerized Axial Tomography Computerized Tomography CT CT Scan Tomography ; Drug: Gallium Ga 68-Edotreotide; Given Intravenously (IV) before imaging; Other Names: Ga-68 DOTA0-Tyr3-octreotide GALLIUM EDOTREOTIDE GA-68 Gallium Ga 68-DOTATOC ; Procedure: Magnetic Resonance Imaging (MRI); Undergo gallium Ga 68-DOTA-TOC PET/MRI; Other Names: Magnetic Resonance Imaging Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MRI MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging ; Procedure: Positron Emission Tomography (PET); Undergo gallium Ga 68-DOTA-TOC PET in combination with CT or MRI; Other Names: Medical Imaging, Positron Emission Tomography PET PET SCAN Positron Emission Tomography Positron Emission Tomography Scan Proton Magnetic Resonance Spectroscopic Imaging

Outcome Measures

Primary Outcome Measures

1. Number of Lesions as Determined by Gallium Ga 68-DOTA-TOC Positron Emission Tomography (PET) Imaging [1 day]

   The 5 largest lesions in each of eight body regions (head and neck, mediastinum, lung, liver, pancreas, the remaining abdomen and pelvis, bone and lymph nodes), will be measured by size (short and long axis) as well as standardized uptake value maximum on conventional imaging and the gallium Ga 68-DOTA-TOC PET imaging. Additionally, the confidence that each lesion represents a metastasis will be recorded The five largest lesions will be (1 = benign, 2 = likely benign, 3 = indeterminant, 4 = likely malignant, 5 = malignant). The number of positive body regions using conventional imaging and Ga-68 DOTA-TOC PET/CT will be compared using a paired t-test (or Wilcoxon signed-rank test if the data appear to be non-normally distributed). The Wilcoxon signed-rank test will also be used to compare reader confidence of paired lesions between conventional imaging and Ga-68 DOTA-TOC PET/CT

2. Standardized Uptake Value Maximum (SUVmax) [1 day]

   The 5 largest lesions in each of eight body regions (head and neck, mediastinum, lung, liver, pancreas, the remaining abdomen and pelvis, bone and lymph nodes), will be measured by size (short and long axis) as well as standardized uptake value maximum on conventional imaging and the gallium Ga 68-DOTA-TOC PET imaging. Additionally, the confidence that each lesion represents a metastasis will be recorded.

3. Inter-reader Variability [1 day]

   Inter-reader variability for the number of positive regions will be compared using Kappa statistics. In all cases we will provide point estimates and 95% confidence intervals for effects along with p-values.

Secondary Outcome Measures

1. Change in Clinical Stage as Determined by Conventional Imaging and Re-determined by Gallium Ga 68-DOTA-TOC PET Imaging [Up to 2 weeks]

   Impact on care will be accessed for value added by the investigational Ga-68 DOTA-TOC PET/CT scan similar to assessment for impact on care as in the National Oncology PET registry. A percentage will then be calculated for both "Change in stage" with a 95% confidence interval determined.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Known or suspected somatostatin receptor positive tumor such as carcinoid; neuroendocrine tumor; neuroblastoma; pheochromocytoma. Supporting evidence may include MRI, CT, biochemical markers, and or pathology report.

• Age > 1.

• Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group (ECOG) / World Health Organization (WHO) equivalent).

• Not pregnant. A negative serum pregnancy test is required for all female subjects with childbearing potential.

• Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

• Hepatic enzymes 5 times greater than the upper limits of normal, serum creatinine > 3.0 mg/dL (270 Micromole per liter (uM/L).

• Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET /CT scanner due to BMI

• Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.); although at Mission Bay Hospital pediatric patients may be sedated per clinical protocol.

• Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.).

• Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.

• Recognized concurrent active infection Previous systemic or radiation treatment for another cancer of any type within the last 2 months.

• Use of any other investigational product or device within 30 days prior to dosing, or known requirement for any other investigational agent prior to completion of all scheduled study assessments

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco	San Francisco	California	United States	94143

Sponsors and Collaborators

• University of California, San Francisco
• Peterson Family Foundation

Investigators

• Principal Investigator: Thomas A Hope, MD, University of California, San Francisco

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 28, 2015
• Informed Consent Form - Nov 3, 2017

More Information

Publications

None provided.

• Responsible Party: Thomas Hope, Assistant Professor of Radiology and Biomedical Engineering, University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT02177773
• Other Study ID Numbers: 14453-HDFCCC; NCI-2017-00451
• First Posted: Jun 30, 2014
• Last Update Posted: Nov 12, 2019
• Last Verified: Oct 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: Neuroblastoma; Neuroendocrine Tumors; Carcinoid Tumor; Paraganglioma; Octreotide; Edotreotide

Study Results

Participant Flow

Arm/Group Title	DOTATOC Imaging
Arm/Group Description	All patients received a single DOTATOC imaging study.
Period Title: Overall Study
STARTED	300
COMPLETED	300
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Ga-68 DOTA-TOC PET/CT
Arm/Group Description	Patients receive gallium Ga 68-DOTA-TOC IV over 1-2 minutes. Within 55-70 minutes, patients then undergo a PET/CT scan over 30-40 minutes or a PET/MRI scan over 50 minutes. Computed Tomography: Undergo gallium Ga 68-DOTA-TOC PET/CT Gallium Ga 68-Edotreotide: Given IV Laboratory Biomarker Analysis: Correlative studies Magnetic Resonance Imaging: Undergo gallium Ga 68-DOTA-TOC PET/MRI Positron Emission Tomography: Undergo gallium Ga 68-DOTA-TOC PET/CT Positron Emission Tomography: Undergo gallium Ga 68-DOTA-TOC PET/MRI
Overall Participants	300
Age, Customized (Count of Participants)
10-19 years	2 0.7%
20-29 years	6 2%
30-39 years	22 7.3%
40-49 years	38 12.7%
50-59 years	71 23.7%
60-69 years	106 35.3%
70-79 years	48 16%
80-89 years	7 2.3%
Sex: Female, Male (Count of Participants)
Female	148 49.3%
Male	152 50.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	28 9.3%
Not Hispanic or Latino	226 75.3%
Unknown or Not Reported	46 15.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	4 1.3%
Asian	14 4.7%
Native Hawaiian or Other Pacific Islander	2 0.7%
Black or African American	8 2.7%
White	201 67%
More than one race	2 0.7%
Unknown or Not Reported	69 23%
Region of Enrollment (participants) [Number]
United States	300 100%

Outcome Measures

1. Primary Outcome

Title	Number of Lesions as Determined by Gallium Ga 68-DOTA-TOC Positron Emission Tomography (PET) Imaging
Description	The 5 largest lesions in each of eight body regions (head and neck, mediastinum, lung, liver, pancreas, the remaining abdomen and pelvis, bone and lymph nodes), will be measured by size (short and long axis) as well as standardized uptake value maximum on conventional imaging and the gallium Ga 68-DOTA-TOC PET imaging. Additionally, the confidence that each lesion represents a metastasis will be recorded The five largest lesions will be (1 = benign, 2 = likely benign, 3 = indeterminant, 4 = likely malignant, 5 = malignant). The number of positive body regions using conventional imaging and Ga-68 DOTA-TOC PET/CT will be compared using a paired t-test (or Wilcoxon signed-rank test if the data appear to be non-normally distributed). The Wilcoxon signed-rank test will also be used to compare reader confidence of paired lesions between conventional imaging and Ga-68 DOTA-TOC PET/CT
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

Since the study agent was approved for the indication by FDA it was decided not to continue investigation and waste resources to analyze data collected to see if the agent is effective for the indication.

Arm/Group Title	DOTATOC Imaging
Arm/Group Description	All patients received a single DOTATOC imaging study.
Measure Participants	0

2. Primary Outcome

Title	Standardized Uptake Value Maximum (SUVmax)
Description	The 5 largest lesions in each of eight body regions (head and neck, mediastinum, lung, liver, pancreas, the remaining abdomen and pelvis, bone and lymph nodes), will be measured by size (short and long axis) as well as standardized uptake value maximum on conventional imaging and the gallium Ga 68-DOTA-TOC PET imaging. Additionally, the confidence that each lesion represents a metastasis will be recorded.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

Since the study agent was approved for the indication by FDA it was decided not to continue investigation and waste resources to analyze data collected to see if the agent is effective for the indication.

Arm/Group Title	DOTATOC Imaging
Arm/Group Description	All patients received a single DOTATOC imaging study.
Measure Participants	0

3. Secondary Outcome

Title	Change in Clinical Stage as Determined by Conventional Imaging and Re-determined by Gallium Ga 68-DOTA-TOC PET Imaging
Description	Impact on care will be accessed for value added by the investigational Ga-68 DOTA-TOC PET/CT scan similar to assessment for impact on care as in the National Oncology PET registry. A percentage will then be calculated for both "Change in stage" with a 95% confidence interval determined.
Time Frame	Up to 2 weeks

Outcome Measure Data

Analysis Population Description

Since the study agent was approved for the indication by FDA it was decided not to continue investigation and waste resources to analyze data collected to see if the agent is effective for the indication.

Arm/Group Title	DOTATOC Imaging
Arm/Group Description	All patients received a single DOTATOC imaging study.
Measure Participants	0

4. Primary Outcome

Title	Inter-reader Variability
Description	Inter-reader variability for the number of positive regions will be compared using Kappa statistics. In all cases we will provide point estimates and 95% confidence intervals for effects along with p-values.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

Since the study agent was approved for the indication by FDA it was decided not to continue investigation and waste resources to analyze data collected to see if the agent is effective for the indication.

Arm/Group Title	DOTATOC Imaging
Arm/Group Description	All patients received a single DOTATOC imaging study.
Measure Participants	0

Adverse Events

Time Frame	Two weeks
Adverse Event Reporting Description	All patients receiving Ga-68 DOTA-TOC were evaluated for safety. Safety parameters include physical findings and spontaneous reports of adverse events (AEs) reported to investigator by patients. Any grade 3 and above AEs were recorded. Patients were followed for two weeks after enrollment by phone, and all AEs were followed with appropriate medical management until resolved.
Arm/Group Title	DOTATOC Imaging
Arm/Group Description	All patients received a single DOTATOC imaging study.
All Cause Mortality
	DOTATOC Imaging
	Affected / at Risk (%)	# Events
Total	0/300 (0%)
Serious Adverse Events
	DOTATOC Imaging
	Affected / at Risk (%)	# Events
Total	0/300 (0%)
Other (Not Including Serious) Adverse Events
	DOTATOC Imaging
	Affected / at Risk (%)	# Events
Total	0/300 (0%)

Limitations/Caveats

Since the study agent was approved for the indication by FDA it was decided not to continue investigation and waste resources to analyze data collected to see if the agent is effective for the indication.

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.