Apudoma, Carcinoid, Carcinoid Tumor, Islet Cell Tumor, Neuroendocrine, Neuroendocrine Cancer, Neuroendocrine Carcinoma, Neuroendocrine Tumor
Conditions
Keywords
gallium, Ga, PET Scan
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.
Interventions
DRUG68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
Sponsors
Ochsner Health System
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Number of lesions detected by 68Ga-DOTATATE compared to conventional imaging techniques | 5 years |
| We want to determine if the 68Ga-DOTATATE PET Scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT) | 5 years |
Countries
United States
Contacts
Primary ContactRichard J. Campeau, M.D.
Outcome results
None listed