68Ga-Dotatate PET for the Study of Somatostatin Receptor Expression in Patients with Poorly-Differentiated Neuroendocrine Carcinomas of the Gastrointestinal Tract

Status: closed to accrual

This phase IV trial studies the extent and degree of somatostatin receptor expression using 68Ga-dotatate PET in patients with poorly-differentiated neuroendocrine carcinomas of the gastrointestinal tract. 68Ga-dotatate is a radioactive substance called a radiotracer. A PET scan is a type of diagnostic imaging scan. Understanding somatostatin receptor expression may help researchers determine if a radiolabeled somatostatin analog therapy can be a potential alternative in the future. It may also help researchers evaluate the potential of radiolabeled somatostatin analog therapy for treatment in patients with poorly-differentiated neuroendocrine carcinomas.

Inclusion Criteria

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Histologically confirmed diagnosis of poorly-differentiated neuroendocrine carcinoma of the gastroenteropancreatic tract or unknown primary
Evidence of measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 on another imagine modality (computed tomography [CT], magnetic resonance imaging [MRI] or fludeoxyglucose F-18 [FDG] PET) with at least 3 tumors > 1 cm in largest diameter. CT, MRI or FDG-PET must have been performed within 2 months of the study scan. (Of note, patients may sign consent for the study prior to scheduling of said CT, MRI or FDG-PET, but will be considered screen failures if the CT/MRI/FDG-PET does not reveal at least 3 tumors > 1 cm)

Exclusion Criteria

Patient with well-differentiated neuroendocrine tumors
Patients who have undergone 68Ga-dotatate PET scan in the past
Pregnant women and/or breastfeeding women. Women of child bearing potential must have a negative pregnancy test prior to scan

PRIMARY OBJECTIVE:

I. Percentage of patients with uniformly positive gallium Ga 68-DOTATATE (68Ga-dotatate) positron emission tomography (PET) (positivity defined as standard uptake value [SUV] uptake > liver for all tumors at least 1 cm in size).

SECONDARY OBJECTIVE:

I. Percentage of patients with no uptake, heterogeneous uptake (tumors showing uptake above and below normal liver), low uptake (maximum [max] SUV =< liver in all tumors), high uptake (max SUV > 2 x liver), very high uptake (max SUV >= kidney or spleen).

OUTLINE:

Patients receive Ga 68-DOTATATE intravenously (IV) and then undergo a PET scan over 45 minutes.

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68Ga-Dotatate PET for the Study of Somatostatin Receptor Expression in Patients with Poorly-Differentiated Neuroendocrine Carcinomas of the Gastrointestinal Tract

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