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

Study Overview

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

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.

N/A

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

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

68Ga-DOTATATE

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-01-14	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2014-01-16
First Submitted that Met QC Criteria 2014-01-16	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2014-01-17
First Posted (ESTIMATED) 2014-01-17	Results First Posted N/A	Last Verified 2014-01

Study Plan

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

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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Scan

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

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

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

Secondary Outcome Measures	Measure Description	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

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

Email:

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

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

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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Clinical Trial Record