Overview

This trial is active, not recruiting.

Condition neuroendocrine carcinoma
Treatment 68ga-dotatate pet scan
Phase phase 1/phase 2
Sponsor Vanderbilt University
Start date August 2011
End date October 2013
Trial size 99 participants
Trial identifier NCT01396382, 110588

Summary

Neuroendocrine cancer is an unusual disease and often goes undetected by routine imaging. The 68Ga-DOTATATE PET scan is a new generation of scans that might have improved sensitivity and resolution specifically for neuroendocrine tumors. The investigators will scan people with this cancer and compare it to other conventional imaging methods to see if it improves patient care.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
We will perform 68Ga-DOTATATE PET scans on subjects
68ga-dotatate pet scan
68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.

Primary Outcomes

Measure
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: One year

Secondary Outcomes

Measure
Number of lesions detected by 68GA-DOTATATE compared to conventional imaging techniques
time frame: one year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Known diagnosis of neuroendocrine tumor - At least 18 years of age - Able to provide informed consent - Karnofsky score greater than 50 - Females of childbearing potential must have a negative pregnancy test at screening/baseline Exclusion Criteria: - Serum creatinine >3.0 mg/dL (270 μM/L) - Hepatic enzyme levels more than 5 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 and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.) - Recognized concurrent active infection - Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.

Additional Information

Official title 68Ga-DOTATATE PET Scanning for Diagnosis and Treatment of Neuroendocrine Tumors
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Vanderbilt University.