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

January 16, 2014 updated by: Richard J. Campeau, M.D., FACNM, Ochsner Health System
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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Richard J. Campeau, M.D.
  • Phone Number: 504-464-8500

Study Locations

    • Louisiana
      • Kenner, Louisiana, United States, 70065
        • Ochsner Medical Center - Kenner

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Scan
We will perform 68Ga-DOTATATE PET scans on subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of lesions detected by 68Ga-DOTATATE compared to conventional imaging techniques
Time Frame: 5 years
5 years
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
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ANTICIPATED)

March 1, 2019

Study Registration Dates

First Submitted

January 14, 2014

First Submitted That Met QC Criteria

January 16, 2014

First Posted (ESTIMATE)

January 17, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 17, 2014

Last Update Submitted That Met QC Criteria

January 16, 2014

Last Verified

January 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neuroendocrine Tumor

3
Subscribe