68Ga-DOTATATE PET Scan in Neuroendocrine Cancer
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Eric H Liu, Vanderbilt University
First received: July 11, 2011
Last updated: December 16, 2013
Last verified: December 2013
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.
Drug: 68Ga-DOTATATE PET scan
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
||68Ga-DOTATATE PET Scanning for Diagnosis and Treatment of Neuroendocrine Tumors
Primary Outcome Measures:
Secondary Outcome Measures:
- 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).
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||October 2013 (Final data collection date for primary outcome measure)
We will perform 68Ga-DOTATATE PET scans on subjects
Drug: 68Ga-DOTATATE PET scan
68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01396382
|Vanderbilt University Medical Center
|Nashville, Tennessee, United States, 37232 |
No publications provided
||Eric H Liu, Assistant Professor, Vanderbilt University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 11, 2011
||December 16, 2013
||United States: Food and Drug Administration
Keywords provided by Vanderbilt University:
islet cell tumor
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 23, 2014
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue