68Ga-DOTATATE PET Scan in Neuroendocrine Cancer (68Ga)
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|ClinicalTrials.gov Identifier: NCT01396382|
Recruitment Status : Completed
First Posted : July 18, 2011
Results First Posted : March 29, 2016
Last Update Posted : March 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Carcinoma||Radiation: 68Ga-DOTATATE PET scan||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||97 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of 68Ga-DOTATATE PET Scanning for Diagnosis and Treatment of Metastatic Neuroendocrine Tumors|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||December 2014|
Experimental: 68Ga-DOTATATE PET
Patients will receive a 68Ga-DOTATATE PET scans
Radiation: 68Ga-DOTATATE PET scan
68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography (PET). Efficacy of the 68Ga-DOTATATE PET scan was assessed and compared to 111In-Pentetreotide scan and to scans with CT and/or MRI. Safety and toxicity were also assessed with pre-injection and post-imaging vital signs, pulse oximetry on room air, 12 lead ECGs, and blood laboratory tests, including tumor markers, liver and renal functions and blood counts, and direct patient questioning. Late delayed tumor markers, liver and renal functions and blood counts were assessed when available.
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01396382
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Ronald C. Walker, MD||Vanderbilt-Ingram Cancer Center|