Description:
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.
Title
- Brief Title: 68Ga-DOTATATE PET Scan Imaging in Patients With Neuroendocrine Tumors
- Official Title: 68Ga-DOTATATE PET Scan Imaging in Patients With Neuroendocrine Tumors
Clinical Trial IDs
- ORG STUDY ID:
68Ga-DOTATATE
- NCT ID:
NCT02038738
Conditions
- Neuroendocrine
- Neuroendocrine Tumor
- Neuroendocrine Cancer
- Neuroendocrine Carcinoma
- Carcinoid
- Carcinoid Tumor
- Islet Cell Tumor
- Apudoma
Interventions
Drug | Synonyms | Arms |
---|
68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography. | | Scan |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Scan | Experimental | We will perform 68Ga-DOTATATE PET scans on subjects. | - 68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
|
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of Participants with Adverse Events as a Measure of Safety and Tolerability |
Time Frame: | 5 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Number of lesions detected by 68Ga-DOTATATE compared to conventional imaging techniques |
Time Frame: | 5 years |
Safety Issue: | |
Description: | |
Measure: | 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 |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Unknown status |
Lead Sponsor: | Ochsner Health System |
Trial Keywords
Last Updated
January 17, 2014