Clinical Trial 19943

• Overview

  Study Title:

  Somatostatin receptor expression in poorly-differentiated neuroendocrine carcinomas of the GI tract: analysis using 68Ga-dotatate PET scan

  Summary:

  There are very limited data on somatostatin-receptor expression in poorly differentiated neuroendocrine carcinomas and somatostatin receptor imaging is rarely performed in this population. A high percentage of patients with high SUV uptake (>liver) would indicate that radiolabeled somatostatin analog therapy may be worthy of further study in this patient population.

  Objective:

  1. Percentage of patients with uniformly positive 68Ga-dotatate PET (positivity defined as SUV uptake > liver for all tumors at least 1cm in size). 2. Percentage of patients with no uptake, heterogeneous uptake (tumors showing uptake above and below normal liver), low uptake (max SUV¡Ü liver in all tumors), high uptake (max SUV > 2x liver), very high uptake (max SUV¡Ý kidney or spleen)

• Inclusion Criteria

  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
  • Male or female ≥ 18 years old
  • Histologically confirmed diagnosis of poorly-differentiated neuroendocrine carcinoma of the gastroenteropancreatic tract or unknown primary
  • Evidence of measurable disease per RECIST 1.1 on another imagine modality (CT, MRI or FDGPET) with at least 3 tumors >1cm 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 >1cm).

• Exclusion Criteria

  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.

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