New PET tracer could spot Hard-to-Find neuroendocrine cancers
NCT ID NCT07132645
First seen Jun 26, 2026 · Last updated Jul 31, 2026 · Updated 1 time
Summary
This early-phase trial is testing a radioactive tracer called FAPI-04 to see how well it lights up high-grade neuroendocrine tumors on PET/CT scans. The study will enroll 30 adults with these aggressive tumors to measure where the tracer goes in the body and how much it accumulates in cancer compared to normal tissues. The goal is to determine if this imaging method could help doctors better detect and monitor these cancers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Gallium Ga 68-DOTA-FAPI-04 (a radioactive tracer for PET scans)
- What this could lead to
- If successful, this could lead to a more accurate imaging method for detecting high-grade neuroendocrine tumors, potentially improving diagnosis and treatment planning.
- What could go wrong
- This is a very early (Phase 1) exploratory study with only 30 participants. It is designed to see where the tracer goes in the body, not to prove it improves outcomes. The tracer may not reliably distinguish tumors from normal tissue.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Michigan Comprehensive Cancer Center
RECRUITINGAnn Arbor, Michigan, 48109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- A simple blood draw could spot tumor relapse before scans do
- Can a radioactive drug shrink Slow-Growing tumours?
- Heart scan bonus: cancer PET may spot inflammation
- New study aims to unlock secrets of lung cancer drug through blood tests
- Can a simple blood test predict cancer risk from radiation therapy?