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Recruiting NCT07132645

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

Early Phase I Interventional Neuroendocrine Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Computed Tomography, Gallium Ga 68-DOTA-FAPI-04, Positron Emission Tomography.
Who it may be relevant to
Registry conditions: Neuroendocrine Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure Computed Tomography
    Undergo CT scan
  • Drug Gallium Ga 68-DOTA-FAPI-04
    Given IV
  • Procedure Positron Emission Tomography
    Undergo PET scan

Primary outcome measures

  • Biodistribution of Gallium Ga 68-DOTA-FAPI-04 ([68Ga]Ga-FAPI-04) [Time frame: Day 1]
  • Pharmacokinetics of [68Ga] Ga-FAPI-04 [Time frame: Day 1]
Secondary outcome measures (3)
  • Tissue concentrations of [68Ga] Ga-FAPI-04 retention in tumors [Time frame: Day 1]
  • Standardized uptake values (SUV) of [68Ga] Ga-FAPI-04 retention in tumors [Time frame: Day 1]
  • Clinical diagnostic performance of [68Ga] Ga-FAPI-04 [Time frame: Day 1]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of Michigan Comprehensive Cancer Center — Ann Arbor

Identifiers

NCT: NCT07132645 · UMCC 2024.069 · NCI-2025-04557 · HUM00237403

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗