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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
97
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.
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Number of Patients That Experienced a Change in Care Plans After 68GA-DOTATATE PET Scan
Determine if the 68Ga-DOTATATE PET scan changes patient care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT, U/S).
Time frame: at 1 year
Number of Severe Adverse Events Occurences Resulting in Changes to Patient Treatment Plans, as a Measure of Safety and Tolerability
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.
Time frame: at 1 year
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