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Search / Trial NCT04069299

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

Launched by H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE · Aug 23, 2019

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a special type of imaging test called a 68Ga-dotatate PET scan to learn more about a specific kind of cancer called poorly differentiated neuroendocrine carcinoma, particularly in the gastrointestinal (GI) tract. The goal is to see how many somatostatin receptors – which are proteins that can help target cancer cells – are present in these tumors. This information may help researchers find out if a treatment called peptide receptor radiotherapy (PRRT) could be a good option for patients in the future.

To be eligible for this study, participants need to be at least 18 years old and have a confirmed diagnosis of poorly differentiated neuroendocrine carcinoma. They should also have evidence of measurable tumors, meaning they need to have at least three tumors larger than 1 cm that have been seen on a recent imaging test like a CT scan or MRI. Participants will need to sign consent to join and be available for the duration of the study. It’s important to note that those with other types of neuroendocrine tumors, those who have had a 68Ga-dotatate PET scan before, and pregnant or breastfeeding women cannot participate. If you join the trial, you can expect to undergo the PET scan and help contribute to important research that may lead to better treatment options for this type of cancer.

Gender

ALL

Eligibility 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 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.

About H. Lee Moffitt Cancer Center And Research Institute

H. Lee Moffitt Cancer Center and Research Institute is a leading institution dedicated to cancer research, treatment, and education, recognized for its commitment to advancing cancer care through innovative clinical trials and groundbreaking research. As a National Cancer Institute-designated Comprehensive Cancer Center, Moffitt integrates cutting-edge science with patient-centered care, offering a multidisciplinary approach to cancer treatment. The center is at the forefront of developing novel therapies and improving outcomes for patients, emphasizing collaboration between researchers and clinicians to translate scientific discoveries into effective treatments. Through its extensive clinical trial programs, Moffitt aims to enhance the understanding of cancer biology and provide patients with access to the latest therapies and interventions.

Locations

Tampa, Florida, United States

Patients applied

0 patients applied

Trial Officials

Jonathan Strosberg, MD

Principal Investigator

H Lee Moffitt Cancer & Research Institute

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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