Use of 68Ga-dotatate PET Scan in Neuroendocrine Carcinoma of the GI Tract

Recruiting

• Conditions: Neuroendocrine Carcinoma
• Interventions: Drug: 68Ga-DOTATATE; Diagnostic Test: Positron Emission Tomography (PET) Scan

• Registration Number: NCT04069299
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

The purpose of the study is to understand the extent and degree of somatostatin receptor expression in poorly differentiated neuroendocrine carcinomas . This may help to make a determination if a radiolabeled somatostatin analog therapy, also referred to as peptide receptor radiotherapy (PRRT), can be a potential alternative in the future. At this time, radiolabeled somatostatin analogs have not been tested in patients with poorly differentiated neuroendocrine carcinomas, and their efficacy in this disease is not well known Understanding the extent and degree of somatostatin receptor expression is important in order to evaluate the potential of radiolabeled somatostatin analog therapy for treatment of poorly differentiated neuroendocrine carcinomas.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-22
• Study First Submitted QC: 2019-08-23
• Study First Posted: 2019-08-28
• Study Start: 2019-09-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-20
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 Fluorodeoxyglucose (FDG)-PET must have been performed within 2 months of the study scan. (Of note, participants 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

• Participants with well-differentiated neuroendocrine tumors
• Participants 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants receiving PET scan	Positron Emission Tomography (PET) Scan	Participants with metastatic poorly-differentiated neuroendocrine carcinomas of the GI tract
Participants receiving PET scan	68Ga-DOTATATE	Participants with metastatic poorly-differentiated neuroendocrine carcinomas of the GI tract

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Uniformly Positive 68Ga-dotatate PET	Up to 10 months	Percentage of participants with uniformly positive 68Ga-dotatate PET (positivity defined as SUV uptake \> liver for all tumors at least 1cm in size). Note: Standard Uptake Value (SUV) is used to determine activity in PET imaging.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants with No Uptake to Very High Uptake on PET	Up to 10 months	Percentage of Participants with no uptake, heterogeneous uptake (tumors showing substantial differences in Somatostatin receptor \[SSTR\] uptake), low uptake (max SUV≤ liver), moderate uptake (liver\<max SUV ≤2x liver, high uptake (max SUV \> 2x liver), very high uptake (max SUV≥ kidney or spleen). Note: Standard Uptake Value (SUV) is used to determine activity in PET imaging.

Trial Locations

Locations (1)

H Lee Moffitt Cancer & Research Institute; 🇺🇸 Tampa, Florida, United States