RECRUITING

An Investigational Scan ([68Ga] Ga-FAPI-04 PET/CT) for the Imaging of Patients With High-Grade Neuroendocrine Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This early phase I trial determines where and to what degree the tracer \[68Ga\] Ga-FAPI-04 accumulates in normal and cancer tissues in patients with high grade neuroendocrine cancer. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research \[68Ga\] Ga-FAPI-04. Because some cancers take up \[68Ga\] Ga-FAPI-04, it can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body.

Official Title

An Exploratory Study of [68Ga]Ga-Fibroblast Activation Protein Inhibitor 4 ([68Ga]Ga-FAPI-04) in Patients With High-Grade Neuroendocrine Neoplasms

Quick Facts

Study Start:2025-10-01
Study Completion:2027-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07132645

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years old
  2. * Current neuroendocrine tumor diagnosis AND high-grade neuroendocrine tumor presentation determined using the following criteria(s):
  3. * Previous low uptake of \[68Ga\] Ga-DOTATATE PET/CT scan OR
  4. * Krenning Score ≥ 3 OR
  5. * Ki67 index ≥ 20%
  6. * Able to lie flat for 60 minutes
  7. * Ability to understand and the willingness to sign a written informed consent
  1. * Pregnancy or lactation
  2. * Patient recently underwent surgery with wound healing

Contacts and Locations

Principal Investigator

Benjamin Viglianti
PRINCIPAL_INVESTIGATOR
University of Michigan Rogel Cancer Center

Study Locations (Sites)

University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan Rogel Cancer Center

  • Benjamin Viglianti, PRINCIPAL_INVESTIGATOR, University of Michigan Rogel Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-10-01
Study Completion Date2027-10-01

Study Record Updates

Study Start Date2025-10-01
Study Completion Date2027-10-01

Terms related to this study

Additional Relevant MeSH Terms

  • Neuroendocrine Tumor