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NCT04069299Completed

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

Somatostatin Receptor Expression in Poorly-Differentiated Neuroendocrine Carcinomas of the GI Tract: Analysis Using 68Ga-dotatate PET Scan

Source: ClinicalTrials.gov · Last updated 31 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
30 (actual)
First submitted
22 Aug 2019
Start date
25 Sept 2019
Primary completion date
2 Jun 2025
Lead sponsor
H. Lee Moffitt Cancer Center and Research Institute
NCT number
NCT04069299

What you commit to

  • Study type: Observational
  • Participants enrolled: 30
  • From 25 Sept 2019 to the primary completion date, 2 Jun 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Pregnant women and/or breastfeeding women. Women of child bearing potential must have a negative pregnancy test prior to scan.

Other

  • Participants with well-differentiated neuroendocrine tumors
  • Participants who have undergone 68Ga-dotatate PET scan in the past

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
H. Lee Moffitt Cancer & Research Institute
Coordinator of this site? Confirm its status
TampaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.