Clinical Trial: 68Ga-DOTATATE PET Scan in Neuroendocrine Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Use of 68Ga-DOTATATE PET Scanning for Diagnosis and Treatment of Metastatic 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 Summary: Eligible participants will undergo baseline assessments at enrollment. Study participants will receive a one-time administration of 68GaDOTATATE and undergo a PET/CT imaging study. Scans will be performed with "negative" oral contrast (e.g. Volumen™ or equivalent), as many NETs involve the GI tract.
Sponsor: Vanderbilt-Ingram Cancer Center

Current Primary Outcome: Number of Patients That Experienced a Change in Care Plans After 68GA-DOTATATE PET Scan [ Time Frame: at 1 year ]

Determine if the 68Ga-DOTATATE PET scan changes patient care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT, U/S).


Original Primary Outcome: Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: One year ]

Determine if any adverse effects are associated with the scan and the number of patients that experience them.


Current Secondary Outcome: Number of Severe Adverse Events Occurences Resulting in Changes to Patient Treatment Plans, as a Measure of Safety and Tolerability [ Time Frame: at 1 year ]

Determine if any adverse effects are associated with the 68Ga-DOTATATE PET scan and the number of patients that experience them using NCI Common Terminology Criteria for Adverse Events v4.0, where: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life‐threatening; Grade 5, death. Toxicities present at baseline and continuing without change in grade were excluded for assessment of this outcome measure.


Original Secondary Outcome: Number of lesions detected by 68GA-DOTATATE compared to conventional imaging techniques [ Time Frame: one year ]

We want to determine if the 68Ga-DOTATATE PET scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT, U/S).


Information By: Vanderbilt-Ingram Cancer Center

Dates:
Date Received: July 11, 2011
Date Started: March 2010
Date Completion:
Last Updated: February 25, 2016
Last Verified: February 2016