New PET tracer could sharpen sarcoma detection

NCT ID NCT04457258

What the study statuses mean

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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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This early-phase trial tests a radioactive tracer called 68Ga-FAPI-46 to see where it collects in the body of people with sarcoma. Participants receive the tracer and undergo a PET/CT scan, which combines a detailed anatomical image (CT) with a functional image (PET) that highlights areas where the tracer accumulates. The goal is to understand how well this tracer binds to sarcoma tumors compared to normal tissues, and to confirm these findings by comparing scan results with tissue samples from surgery or biopsy.

What this could mean

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

Active substance
a radioactive tracer called 68Ga-FAPI-46, given intravenously, used with PET/CT imaging
What this could lead to
If successful, this imaging technique could help doctors better detect and monitor sarcoma, potentially guiding treatment decisions.
What could go wrong
This is a very early, small study (18 people) focused on imaging, not treatment. The tracer may not clearly distinguish cancer from normal tissue, and results may not apply to other cancers.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

18 people

The number who actually took part.

Started

Sep 2020

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

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: * Patients who are scheduled to undergo surgical excision or biopsy of a suspected sarcoma primary, or a suspected recurrent or metastatic lesion. * Patients who are ≥ 18 years old at the time of the radiotracer administration. * Patients who can provide written informed consent. * Patients who are able to remain still for duration of imaging procedures (up to one hour for each). Exclusion Criteria: * Patient is pregnant or nursing. * Patients with any new cancer therapy between the baseline 18F-FDG PET/CT and the investigational FAPI PET/CT * Patient has underlying disease which, based on the judgment of the investigator, might interfere with the collection of high quality data.

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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

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095, United States

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