68Ga-DOTATATE PET Scan in Neuroendocrine Cancer

This study is currently recruiting participants.

Verified November 2012 by Vanderbilt University

Sponsor:

Information provided by (Responsible Party):

Eric H Liu, Vanderbilt University

ClinicalTrials.gov Identifier:

NCT01396382

First received: July 11, 2011

Last updated: April 9, 2013

Last verified: November 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 11, 2011
Last Updated Date	April 9, 2013
Start Date ^ICMJE	August 2011
Estimated Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 14, 2011)	Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: One year ] [ Designated as safety issue: Yes ] Determine if any adverse effects are associated with the scan and the number of patients that experience them.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01396382 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 14, 2011)	Number of lesions detected by 68GA-DOTATATE compared to conventional imaging techniques [ Time Frame: one year ] [ Designated as safety issue: No ] We want to determine if the 68Ga-DOTATATE PET scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT, U/S).
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	68Ga-DOTATATE PET Scan in Neuroendocrine Cancer
Official Title ^ICMJE	68Ga-DOTATATE PET Scanning for Diagnosis and Treatment of Neuroendocrine Tumors
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Condition ^ICMJE	Neuroendocrine Carcinoma
Intervention ^ICMJE	Drug: 68Ga-DOTATATE PET scan 68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
Study Arm (s)	Experimental: Scan We will perform 68Ga-DOTATATE PET scans on subjects Intervention: Drug: 68Ga-DOTATATE PET scan
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	100
Estimated Completion Date	August 2013
Estimated Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01396382
Other Study ID Numbers ^ICMJE	110588
Has Data Monitoring Committee	Yes
Responsible Party	Eric H Liu, Vanderbilt University
Study Sponsor ^ICMJE	Vanderbilt University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Vanderbilt University
Verification Date	November 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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