An Early Phase 1 interventional study of Computed Tomography and Gallium Ga 68-DOTA-FAPI-04 in Neuroendocrine Tumor, sponsored by University of Michigan Rogel Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by University of Michigan Rogel Cancer Center · Early Phase 1, Interventional, and Basic science
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 218 studies in Neuroendocrine Tumors with a site in United States — 44 open to participants now, 77 under way, 10 of them phase 3. Neuroendocrine Tumors · United States.
Among the 218 studies in Neuroendocrine Tumors with a site in United States, this one is the 107th largest by planned enrollment of the 189 interventional ones that give a count, is one of 16 that started in 2025, is one of 47 in phase 1, reaches primary completion later than 42 of the 75 other live ones, and was the 210th registered.
542 studies on the registry are indexed under Neuroendocrine Tumors; 135 are open to participants now.
Browse Neuroendocrine Tumors studies →44 of the 218 studies in Neuroendocrine Tumors with a site in United States are open now. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States
Ages 18–120
Washington University School of Medicine · Sites in United States
Ages 18+
Compass Therapeutics · Sites in United States
Ages 18+
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Sites in United States, Brazil, France and 6 more countries
Ages 18+
Washington University School of Medicine · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 112 Neuroendocrine Tumors studies recruiting now, 73 (65%) set no upper age limit and 17 (15%) stop at 75 or younger; 12 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
218 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 72 · Phase 2 110 · Phase 3 18 · Phase 4 5
First in 2001; this study’s year is marked. 16 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 41 across 387 interventional studies indexed under Neuroendocrine Tumors.
Median enrollment 36 across the 189 interventional studies, 203 across the 24 observational. Of the 125 that completed or were terminated, 70 (56%) have results posted.
This tab as a report to print or save as PDF → With an account.
73 of 218 have an industry lead sponsor. The 10 most frequent:
University of Michigan Rogel Cancer Center is the lead sponsor of 325 studies on the registry; 49 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 31 (67%) have results posted.
University of Michigan Rogel Cancer Center has 3 studies filed under Neuroendocrine Tumors — fewer than ten, so there is no comparison to draw.
29 of the studies in Neuroendocrine Tumors with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05477576Phase 3RayzeBio, Inc.Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy | 2026-12 |
| NCT04919226Phase 3ITM Solucin GmbHLutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE | 2027-06 |
| NCT07087054Phase 3Crinetics Pharmaceuticals Inc.Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen | 2027-08 |
| NCT06881992Phase 3RezoluteA Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism | 2027-09 |
| NCT05263050Fox Chase Cancer CenterTrial of an Alternative Cabozantinib Dosing Schedule in Metastatic Renal Cell Carcinoma and Neuroendocrine Tumors | 2026-12 |
Add all 29 to your calendar (.ics) → With an account.
Among the 218 studies in Neuroendocrine Tumors with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Current neuroendocrine tumor diagnosis AND high-grade neuroendocrine tumor presentation determined using the following criteria(s):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive \[68Ga\] Ga-FAPI-04 IV, followed 1 hour later by PET/CT scan over approximately 25 minutes.
Procedure: Computed Tomography · Drug: Gallium Ga 68-DOTA-FAPI-04 · Procedure: Positron Emission Tomography
Undergo CT scan
Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography
Given IV
Also known as: 68Ga-DOTA-FAPI-04, 68Ga-FAPi-04, GALLIUM GA-68-DOTA-FAPI-04, Gallium-68-FAPi-04
Undergo PET scan
Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT
Biodistribution of Gallium Ga 68-DOTA-FAPI-04 ([68Ga]Ga-FAPI-04)
Time frame: 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.
Time frame: Day 1
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
Will compare the difference in SUVmax uptake within each subject using a two-side, one-sample t-test.
Time frame: 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.
Time frame: Day 1
Plan to share: Undecided
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Sep 2027, 23 months after the start.
Of 54 phase 1 interventional studies under Neuroendocrine Tumors, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 75. This study's planned 23 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: 68Ga-FAPI
University of Michigan Rogel Cancer Center →