NCT07132645RecruitingEarly phase 1
An Investigational Scan ([68Ga] Ga-FAPI-04 PET/CT) for the Imaging of Patients With High-Grade Neuroendocrine Cancer
An Exploratory Study of [68Ga]Ga-Fibroblast Activation Protein Inhibitor 4 ([68Ga]Ga-FAPI-04) in Patients With High-Grade Neuroendocrine Neoplasms
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 14 Jul 2025
- Start date
- 16 Sept 2025
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Diseases
- Neuroendocrine tumours
- NCT number
- NCT07132645
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 30
- From 16 Sept 2025 to the primary completion date, 1 Sept 2027
- 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
- Patient recently underwent surgery with wound healing
Other
- Pregnancy or lactation
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Of Michigan Comprehensive Cancer Center Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.