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New radioactive tracer could sharpen breast cancer scans

NCT ID NCT05226663

Diagnosis Sponsor: M.D. Anderson Cancer Center Source: ClinicalTrials.gov ↗

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether a new radioactive tracer called [18F]FluorThanatrace can improve PET/CT scans in 36 people with breast cancer. The tracer is designed to highlight an enzyme linked to cancer growth. Participants will receive the tracer before their standard surgery or biopsy, and researchers will compare the scan results with tissue samples to see if the tracer accurately spots cancer activity.

What this could mean

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

Active substance
[18F]FluorThanatrace (a radioactive tracer)
What this could lead to
If successful, this could lead to a more precise imaging method to detect breast cancer activity, helping doctors tailor treatments.
What could go wrong
This is a small, early-phase trial with only 36 participants. The tracer may not reliably show enzyme activity in all patients, and results may not apply to everyone.

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

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Aug 2026

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

Accepted

You do not need to have the condition being studied to take part.

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: * Participants will be \>= 18 years of age * Known primary breast cancer. For subjects with primary breast cancer we will target lesion size of 1.0 cm or greater on at least one type of standard clinical imaging (e.g. mammogram, ultrasound, breast magnetic resonance imaging \[MRI\]) * A candidate for primary breast surgery (mastectomy or lumpectomy) * Participants must be informed of the investigational nature of this study and provide written informed consent, in accordance with institutional and federal guidelines prior to study-specific procedures Exclusion Criteria: * Females who are pregnant or breast feeding will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential prior to injection of FTT * Inability to tolerate imaging procedures in the opinion of an investigator or treating physician * Current or prior therapy for the primary breast cancer * Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast carcinoma

Contacts and locations

Locations

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Siteman Cancer Center at Washington University

    St Louis, Missouri, 63110, United States

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104, United States

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