Neuroendocrine TumorEarly Phase 1NCT07132645
An Investigational Scan ([68Ga] Ga-FAPI-04 PET/CT) for the Imaging of Patients With High-Grade Neuroendocrine Cancer
A Early Phase 1 study testing Computed Tomography, Gallium Ga 68-DOTA-FAPI-04 and Positron Emission Tomography in people with Neuroendocrine Tumor, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumor
- What is being tested?
- Computed Tomography, Gallium Ga 68-DOTA-FAPI-04 and Positron Emission Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2025to 1 Sep 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy or lactation
- Patient recently underwent surgery with wound healing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Benjamin Viglianti, 734-936-5385, bviglia@med.umich.edu
Benjamin Viglianti
About this study
Official title: An Exploratory Study of [68Ga]Ga-Fibroblast Activation Protein Inhibitor 4 ([68Ga]Ga-FAPI-04) in Patients With High-Grade Neuroendocrine Neoplasms
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.
- Conditions
- Neuroendocrine Tumor
- Being tested
- Computed Tomography, Gallium Ga 68-DOTA-FAPI-04, Positron Emission Tomography
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT scan
Gallium Ga 68-DOTA-FAPI-04Drug
Also called 68Ga-DOTA-FAPI-04, 68Ga-FAPi-04, GALLIUM GA-68-DOTA-FAPI-04, Gallium-68-FAPi-04
Given IV
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET scan
| Study group | Role | What they receive |
|---|---|---|
| Basic science ([68Ga] Ga-FAPI-04) | Experimental | Patients receive [68Ga] Ga-FAPI-04 IV, followed 1 hour later by PET/CT scan over approximately 25 minutes. Receives: Procedure: Computed Tomography; Drug: Gallium Ga 68-DOTA-FAPI-04; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodistribution of Gallium Ga 68-DOTA-FAPI-04 ([68Ga]Ga-FAPI-04)
Measured: Day 1
Pharmacokinetics of [68Ga] Ga-FAPI-04
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.
Measured: Day 1
Secondary outcomes (3)
Tissue concentrations of [68Ga] Ga-FAPI-04 retention in tumors
Measured: Day 1
Standardized uptake values (SUV) of [68Ga] Ga-FAPI-04 retention in tumors
Will compare the difference in SUVmax uptake within each subject using a two-side, one-sample t-test.
Measured: Day 1
Clinical diagnostic performance of [68Ga] Ga-FAPI-04
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start16 Sep 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Neuroendocrine Research Foundation
- Responsible party
- Sponsor
- Investigators
- Benjamin Viglianti, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132645
- Sponsor's protocol ID
- UMCC 2024.069
- Other IDs
- NCI-2025-04557, HUM00237403
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of [68Ga]Ga-Fibroblast Activation Protein Inhibitor 4 ([68Ga]Ga-FAPI-04) in Patients With High-Grade Neuroendocrine Neoplasms
- ClinicalTrials.gov ID
- NCT07132645
- Acronym / sponsor ID
- UMCC 2024.069
- Conditions
- Neuroendocrine Tumor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Neuroendocrine Research Foundation
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Basic science ([68Ga] Ga-FAPI-04) | Experimental | Procedure: Computed Tomography, Drug: Gallium Ga 68-DOTA-FAPI-04, Procedure: Positron Emission TomographyPatients receive [68Ga] Ga-FAPI-04 IV, followed 1 hour later by PET/CT scan over approximately 25 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years old
- Current neuroendocrine tumor diagnosis AND high-grade neuroendocrine tumor presentation determined using the following criteria(s):
- Able to lie flat for 60 minutes
- Ability to understand and the willingness to sign a written informed consent
Key exclusion criteria (2 listed)
- Pregnancy or lactation
- Patient recently underwent surgery with wound healing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT scan | Procedure or surgery | Basic science ([68Ga] Ga-FAPI-04) |
| Gallium Ga 68-DOTA-FAPI-04Also: 68Ga-DOTA-FAPI-04, 68Ga-FAPi-04, GALLIUM GA-68-DOTA-FAPI-04, Gallium-68-FAPi-04Given IV | Drug | Basic science ([68Ga] Ga-FAPI-04) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)Undergo PET scan | Procedure or surgery | Basic science ([68Ga] Ga-FAPI-04) |
Primary outcome
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
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University of Michigan Comprehensive Cancer Center
Ann Arbor, United States
Benjamin Viglianti principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Computed Tomography, Gallium Ga 68-DOTA-FAPI-04 and Positron Emission Tomography in people with Neuroendocrine Tumor, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodistribution of Gallium Ga 68-DOTA-FAPI-04 ([68Ga]Ga-FAPI-04) (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.