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NCT Number: NCT07132645

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

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.

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Key information

Conditions

Neuroendocrine Tumor Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Benjamin Viglianti

CONTACT

[email protected]

734-936-5385

Benjamin Viglianti

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years old
  • Current neuroendocrine tumor diagnosis AND high-grade neuroendocrine tumor presentation determined using the following criteria(s):
  • Previous low uptake of [68Ga] Ga-DOTATATE PET/CT scan OR
  • Krenning Score ≥ 3 OR
  • Ki67 index ≥ 20%
  • Able to lie flat for 60 minutes
  • Ability to understand and the willingness to sign a written informed consent

Exclusion criteria

  • Pregnancy or lactation
  • Patient recently underwent surgery with wound healing

Treatment and study plan

Computed Tomography

Procedure

Undergo CT scan

Other names: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Gallium Ga 68-DOTA-FAPI-04

Drug

Given IV

Other names: 68Ga-DOTA-FAPI-04, 68Ga-FAPi-04, GALLIUM GA-68-DOTA-FAPI-04, Gallium-68-FAPi-04

Positron Emission Tomography

Procedure

Undergo PET scan

Other names: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Primary outcomes

  1. Biodistribution of Gallium Ga 68-DOTA-FAPI-04 ([68Ga]Ga-FAPI-04)

    Time frame: Day 1

  2. Pharmacokinetics of [68Ga] Ga-FAPI-04

    Time frame: Day 1

    We will monitor/measure the amount of Ga-FAPI-04 seen within different tissue in patients that have neuroendocrine tumors. We will specifically measure the ratio of uptake in the tumors in comparison to reference tissues such as liver or muscle.

Secondary outcomes

  1. Tissue concentrations of [68Ga] Ga-FAPI-04 retention in tumors

    Time frame: Day 1

  2. Standardized uptake values (SUV) of [68Ga] Ga-FAPI-04 retention in tumors

    Time frame: Day 1

    Will compare the difference in SUVmax uptake within each subject using a two-side, one-sample t-test.

  3. Clinical diagnostic performance of [68Ga] Ga-FAPI-04

    Time frame: Day 1

    When a comparison Ga-DOTATATE scan is available, we will look at the uptake in the tumor in the SOC image related to reference tissue and then compare the FAPI-04 uptake.

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

  • Neuroendocrine Research Foundation

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 20, 2025
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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