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New scan could catch breast cancer spread that standard tests miss

NCT ID NCT07313033

Diagnosis Sponsor: Hospices Civils de Lyon 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new type of PET scan using a tracer called 68Ga-FAPI-46 to find cancer that has spread in patients with lobular breast cancer. Standard scans often miss these metastases. The trial will enroll 45 adults whose standard PET scan was negative or unclear, and see if the new scan can spot hidden lesions confirmed by biopsy. If it works, it could lead to better treatment decisions.

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 (a radioactive tracer for PET scans)
What this could lead to
If successful, this could provide a more accurate way to detect breast cancer spread, helping patients avoid undertreatment.
What could go wrong
This is a very early, small study (45 people) with no results yet. The new scan may not find more lesions than the standard scan, and false positives are possible.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 45 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Aug 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

Female participants only

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: * Adult patient (≥18 years old), * Beneficiary or entitled to a social security system; * Patient having agreed to participate in the study and signed written informed consent; * 18F-FDG PET/CT performed as part of the assessment of extension of an infiltrating lobular carcinoma, the result of which is negative or doubtful on at least one lesion. Exclusion Criteria: * Pregnant, parturient or breastfeeding women. A pregnancy test before inclusion will be carried out for women of childbearing age. * Persons deprived of liberty by a judicial or administrative decision * People receiving psychiatric care * People admitted to a health or social establishment for purposes other than research * Adults subject to a legal protection measure (guardianship, curatorship) * Subjects participating in another interventional research including an exclusion period still ongoing at inclusion.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Carcinoma, Lobular invasive lobular breast carcinoma neoplasm

As listed by the trial registrant

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

Breast cancer Lobular carcinoma

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

  • Lyon sud Hospital center - Hospices Civils de Lyon

    Lyon, France

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