Radioactive tracer aims to light up hidden lung scarring
NCT ID NCT07817563
First seen Sep 14, 2026 · Last updated Sep 18, 2026 · Updated 2 times
Summary
Researchers at Mayo Clinic are testing an investigational radioactive tracer called 68Ga-FAPI-46 to see how it distributes in the lungs of people with interstitial lung disease. About 10 participants with a clinical diagnosis of ILD and lung abnormalities on a recent CT scan receive the tracer by IV, then undergo a PET/CT scan roughly an hour later. The study measures how much tracer collects in abnormal versus normal lung tissue and compares the scan against standard diagnostic CT findings. The goal is to learn whether this imaging approach can detect and map ILD.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 68Ga-FAPI-46, an investigational radioactive imaging tracer given by IV before a PET/CT scan
- What this could lead to
- If the tracer highlights scarred lung tissue well, doctors could gain a new way to see and track interstitial lung disease earlier or more precisely than standard CT scans alone.
- What could go wrong
- This is a tiny Phase 1 imaging study of about 10 people, so it cannot prove the scan improves diagnosis or outcomes. The tracer may not bind scar tissue reliably, and radiation exposure and false positives are possible.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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May 2031
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: * Clinical diagnosis of interstitial lung disease * Radiologic lung abnormalities on diagnostic CT chest * Anatomic imaging (clinical diagnostic CT chest) obtained within ≤ 180 days prior to the planned FAPI 46 imaging exam or within 14 days after the imaging exam. * Willingness and ability to provide informed consent Exclusion Criteria: * Pregnant as determined by a pregnancy test as per institutional guidelines for individuals of child-bearing potential * Declining to use effective contraceptive methods during the study (for individuals of child-producing potential) * Need for emergent surgery that would be delayed by participation * Bacterial, viral, or fungal infections requiring systemic therapy * Serious co-morbidities and serious nonmalignant disease (e.g., hydronephrosis, kidney failure, liver failure, or other conditions) that in the opinion of the investigator, physician of record and/or Sofie could compromise patient safety and/or protocol objectives. * No available chest CT radiological data * No clear diagnosis of ILD * Intolerability to perform the exam due to exuberant dyspnea or severely low pulmonary capacity. * Breastfeeding. Note: nursing parents are allowed if the potential participant commits to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of the \[68Ga\]FAPI-46 injection. * Known hypersensitivity to any excipients used in \[68Ga\]FAPI-46
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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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Mayo Clinic
Rochester, Minnesota, 55905, United States
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