68Ga-DOTATATE PET Scan Imaging in Patients With Neuroendocrine Tumors

Ochsner Health System

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Islet Cell Tumor

Neuroendocrine

Carcinoid Tumor

Neuroendocrine Cancer

Carcinoid

Neuroendocrine Carcinoma

Apudoma

Neuroendocrine Tumor

Treatments

Drug: 68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.

Study type

Interventional

Funder types

Other

Identifiers

NCT02038738

68Ga-DOTATATE

Details and patient eligibility

About

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.

Enrollment

250 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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