Comparator Study of 68Ga-DOTATOC PET/CT With Octreoscan + High-resolution, Contrast-enhanced CT for Diagnosis and Staging in Neuroendocrine Tumors and Other Somatostatin Receptor Positive Tumors
I. To compare efficacy of [68Ga]-DOTA-tyr3-Octreotide (68Ga-DOTATOC) (gallium Ga
68-edotreotide) PET/CT with Octreoscan (indium In 111 pentetreotide) + high-resolution,
contrast-enhanced CT for diagnosis and staging in patients with somatostatin receptor
Patients receive gallium Ga 68-edotreotide intravenously (IV) and undergo PET/CT scan.
Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT
or MRI scan. Patients may also undergo a second gallium Ga 68-edotreotide PET/CT scan within
3-6 months if the lesions of the first scan cannot be confirmed.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
Equivalence of conventional imaging and gallium Ga 68-edotreotide PET using percentage of concordance in tumor detection
Binomial exact tests will be used.
Up to 6 months
M. Sue O' Dorisio
University of Iowa
United States: Food and Drug Administration
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