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

NCT ID: NCT02038738

Last Updated: 2014-01-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31

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.

Conditions

Neuroendocrine; Neuroendocrine Tumor; Neuroendocrine Cancer; Neuroendocrine Carcinoma; Carcinoid; Carcinoid Tumor; Islet Cell Tumor; Apudoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Scan

We will perform 68Ga-DOTATATE PET scans on subjects.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Interventions

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ochsner Health System

OTHER

Sponsor Role: lead

Responsible Party

Richard J. Campeau, M.D., FACNM

Professor of Radiology and Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ochsner Medical Center - Kenner

Kenner, Louisiana, United States

Countries

United States

Central Contacts

Richard J. Campeau, M.D.

Role: CONTACT

504-464-8500

Other Identifiers

68Ga-DOTATATE

Identifier Type: -

Identifier Source: org_study_id