68-Ga-DOTATATE PET-CT Scan for Diagnosis and Staging of Neuroendocrine Tumors
The number of lesions that could be identified clearly as single foci will be determined for
each patient. The same anatomic areas will be imaged with 68Ga-DOTATATE PET and
111In-penteoctreotide Scintigraphy to ensure relevant comparison of lesion detection.
Because of confluence and inability to clearly delineate single liver lesions in some cases,
liver metastases will be classified as 1 organ metastasis, independent of the number of
liver metastases present. Lymph nodes smaller than 1 cm on CT or MRI and showing marked
avidity for 68Ga- DOTATATE and 111In-penteoctreotide will be labeled as positive for
disease. The presence of lesions will be confirmed by cross-sectional imaging of all
patients with CT or MRI.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Number of lesions detected by 68GA-DOTATATE compared to conventional imaging technique
We want to determine if the 68Ga-DOTATATE PET/CT scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI).
Ebrahim Delpassand, MD
United States: Food and Drug Administration
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