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New PET tracer could sharpen cancer detection

NCT ID NCT05641896

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new radioactive tracer called [18F]FAPI-74 for PET scans in people with gastrointestinal cancers, including liver, bile duct, stomach, pancreatic, and colorectal cancers. The goal was to see if the tracer can accurately detect cancer cells by comparing scan results with tissue samples. A total of 109 participants were enrolled, and the study has been completed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
[18F]FAPI-74 (a radioactive tracer for PET imaging)
What this could lead to
If successful, this imaging method could help doctors more accurately detect and locate gastrointestinal cancers, potentially guiding better treatment decisions.
What could go wrong
This is a phase 2 study with a moderate number of participants. The imaging agent may not prove more effective than current methods, and results may not apply to all cancer types.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

109 people

The number who actually took part.

Started

Apr 2023

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Confirmed diagnosis of gastrointestinal (GI) malignancy, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer * Available tissue sample obtained through biopsy or to be obtained through scheduled biopsy and/or surgical resection * No treatment received between tissue sample taken and \[18F\]FAPI-74 PET * Anatomic imaging (e.g., CT, MRI) obtained within ≤ 28 days of consent * Age ≥ 18 years * Completed informed consent as determined per the IRB of record 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, that are expected to impact FAP expression in the opinion of the sponsor or their designee * Serious co-morbidities and serious nonmalignant disease (e.g., hydronephrosis, kidney failure, liver failure, systemic or local inflammatory or autoimmune diseases or other conditions) that in the opinion of the investigator, physician of record and/or Sofie could compromise subject safety and/or protocol objectives * Known diagnosis of an autoimmune disorder that is expected to impact FAP expression in the opinion of the sponsor or their designee * Patients receiving any other investigational agent within the past 28 days * 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 \[18F\]FAPI-74 injection * Known hypersensitivity to any excipients used in \[18F\]FAPI-74: trace amounts of sodium acetate, sodium ascorbate, ascorbic acid, ethanol, acetonitrile or AlCl. * Renal or liver function impairment\* \*Defined by liver impairments as AST\>3x the upper limit of normal, ALT\>3x the upper limit of normal, or bilirubin\>1.5x the upper limit of normal. Renal impairment as defined by a creatinine clearance of \>1.5x the upper limit of normal utilizing the Cockcroft Gault formula

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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.

Contacts and locations

Locations

  • BAMF Health

    Grand Rapids, Michigan, 49503, United States

  • Massachusetts general hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55902, United States

  • Memorial Sloan Kettering Cancer Center (MSKCC)

    New York, New York, 10065, United States

  • Northwell Health

    Lake Success, New York, 11042, United States

  • University of California Los Angeles (UCLA) Health

    Los Angeles, California, 90095, United States

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