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New PET tracer could reveal hidden breast cancer throughout the body

NCT ID NCT04824014

Diagnosis Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 10, 2026 · Last updated Jul 10, 2026

Summary

This phase 2 trial tests a new radioactive tracer called 4FMFES for PET scans in people with advanced estrogen receptor positive (ER+) breast cancer. The tracer binds to estrogen receptors, allowing doctors to see where the cancer has spread anywhere in the body. The study aims to see if combining 4FMFES-PET with standard FDG-PET gives a more complete picture of the disease, helping guide treatment decisions and predict outcomes.

What this could mean

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

Active substance
4FMFES (a radioactive tracer for PET imaging)
What this could lead to
If successful, this imaging method could become a standard tool for whole-body assessment of estrogen receptor status, helping doctors choose the best treatment for advanced breast cancer without repeated biopsies.
What could go wrong
This is a phase 2 trial with 150 participants, so it is still early. The tracer may not prove superior to existing methods in real-world use, and its availability may be limited.

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 150 people

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

Started

Nov 2020

Expected to finish

Dec 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

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: * Advanced breast cancer patients, i.e. stage 3 or 4 diseases. * Aged 18 or older at the time of breast cancer diagnosis. * Histopathologic review confirming diagnosis of ER positive breast cancer. * Male patients, although rare, can participate. * Patient must have given informed consent. * ECOG performance status 0-3. * ER must be positive in at least 10% of tumor cells in either the core biopsy or a therapeutic surgical resection. * Any HER2-neu status. * Patient eligible for and willing to receive systemic treatment. Exclusion Criteria: * Patients who are pregnant or nursing. * Patients unable to tolerate PET/CT for 30 minutes. * Patients taking anti-ER hormone therapy that can pharmacologically blockade estrogen receptors (ex: Tamoxifen, Fulvestrant). Patients can undergo 4FMFES-PET if anti-ER therapy was interrupted at least 8 weeks prior imaging. Aromatase inhibitors and LHRH analogs are not expected to interfere with 4FMFES uptake and are thus permitted to be taken prior and during this study.

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Conditions

The condition(s) this trial relates to.

estrogen-receptor positive breast cancer

As listed by the trial registrant

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

ER+ breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Université deSherbrooke

    RECRUITING

    Sherbrooke, Quebec, J1H5N4, Canada

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