Back to results68Ga-DOTATATE PET Scan Imaging in Patients With Neuroendocrine Tumors
Primary Purpose
Neuroendocrine, Neuroendocrine Tumor, Neuroendocrine Cancer
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
Sponsored by
About this trial
This is an interventional diagnostic trial for Neuroendocrine focused on measuring gallium, Ga, PET Scan
Eligibility Criteria
Inclusion Criteria:
- Known diagnosis of neuroendocrine tumor or suspected SSTR positive tumors by 111In-Octreotide scan, 18FDG-PET, or MRI of the abdomen where clinically indicated
- At least 18 years of age
- Able to provide informed consent
- Karnofsky performance score greater than 50
- Females of childbearing potential must have a negative pregnancy test at screening/baseline
Exclusion Criteria:
- Serum creatinine > 2.0 mg/dL
- Hepatic enzyme levels more than 3 times upper limit of normal
- Known severe allergy or hypersensitivity to IV radiographic contrast
- 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
- Patients with a body weight of 400 pounds or more or not able to enter the bore of the PET/CT scanner due to BMI, because of the compromise in image quality with CT, PET/CT, and MRI that will result
- Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.)
- Inability to complete the needed investigational standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
- Recognized concurrent active infection
- Previous systemic or radiation treatment for another cancer of any type within the last 2 years
- Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
Sites / Locations
- Ochsner Medical Center - Kenner
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Scan
Arm Description
We will perform 68Ga-DOTATATE PET scans on subjects.
Outcomes
Primary Outcome Measures
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Secondary Outcome Measures
Number of lesions detected by 68Ga-DOTATATE compared to conventional imaging techniques
We want to determine if the 68Ga-DOTATATE PET Scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT)
Full Information
NCT ID
NCT02038738
First Posted
January 14, 2014
Last Updated
January 16, 2014
Sponsor
Ochsner Health System
1. Study Identification
Unique Protocol Identification Number
NCT02038738
Brief Title
68Ga-DOTATATE PET Scan Imaging in Patients With Neuroendocrine Tumors
Official Title
68Ga-DOTATATE PET Scan Imaging in Patients With Neuroendocrine Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ochsner Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Neuroendocrine cancer is an unusual disease and often goes undetected by routine imaging. The 68Ga-DOTATATE PET Scan is a novel scanning method that may have improved sensitivity and resolution specifically for neuroendocrine tumors. Patients with neuroendocrine tumors will be imaged with this agent and it will be compared to conventional imaging methods to determine the safety and efficacy of this radiopharmaceutical.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine, Neuroendocrine Tumor, Neuroendocrine Cancer, Neuroendocrine Carcinoma, Carcinoid, Carcinoid Tumor, Islet Cell Tumor, Apudoma
Keywords
gallium, Ga, PET Scan
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Scan
Arm Type
Experimental
Arm Description
We will perform 68Ga-DOTATATE PET scans on subjects.
Intervention Type
Drug
Intervention Name(s)
68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Number of lesions detected by 68Ga-DOTATATE compared to conventional imaging techniques
Time Frame
5 years
Title
We want to determine if the 68Ga-DOTATATE PET Scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT)
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Known diagnosis of neuroendocrine tumor or suspected SSTR positive tumors by 111In-Octreotide scan, 18FDG-PET, or MRI of the abdomen where clinically indicated
At least 18 years of age
Able to provide informed consent
Karnofsky performance score greater than 50
Females of childbearing potential must have a negative pregnancy test at screening/baseline
Exclusion Criteria:
Serum creatinine > 2.0 mg/dL
Hepatic enzyme levels more than 3 times upper limit of normal
Known severe allergy or hypersensitivity to IV radiographic contrast
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
Patients with a body weight of 400 pounds or more or not able to enter the bore of the PET/CT scanner due to BMI, because of the compromise in image quality with CT, PET/CT, and MRI that will result
Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.)
Inability to complete the needed investigational standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Recognized concurrent active infection
Previous systemic or radiation treatment for another cancer of any type within the last 2 years
Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard J. Campeau, M.D.
Phone
504-464-8500
Facility Information:
Facility Name
Ochsner Medical Center - Kenner
City
Kenner
State/Province
Louisiana
ZIP/Postal Code
70065
Country
United States
12. IPD Sharing Statement
Learn more about this trial
68Ga-DOTATATE PET Scan Imaging in Patients With Neuroendocrine Tumors
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