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New PET scan may better predict chemo success in breast cancer

NCT ID NCT07553741

Diagnosis Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether a newer type of PET scan (68Ga-FAPI) can better predict if breast cancer has been fully eliminated by chemotherapy compared to standard PET scans (18F-FDG) and MRI. Twenty-seven women with breast cancer had all three scans before and after chemotherapy, then surgery to check results. The goal is to see which scan most accurately identifies complete response, potentially guiding future 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-04 and 18F-FDG (imaging agents)
What this could lead to
If successful, this could show that a newer PET scan (FAPI) is more accurate than standard scans at predicting whether breast cancer has been eliminated by chemotherapy, helping doctors make better treatment decisions.
What could go wrong
This is a small, early study with only 27 participants, so results may not apply to all breast cancer patients. The imaging agents are for diagnosis only and do not treat the cancer.

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

27 people

The number who actually took part.

Started

Apr 2025

Finished

Apr 2026

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 to 70 years

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: Female, aged 18-70 years Pathologically confirmed primary breast cancer TNM stage T2-4N0M0/T1-4N1-3M0 No prior treatment No severe hematologic, cardiac, pulmonary, hepatic, or renal dysfunction, and no immunodeficiency diseases Patients must have good physical condition, ECOG score of 0-1 Female patients of childbearing potential must agree to use effective contraception during the study Signed written informed consent Exclusion Criteria: Unwilling to undergo 68Ga-FAPI PET/MRI scan Unable to tolerate chemotherapy or surgery Previous history of other malignancies or prior antitumor treatment Evidence of distant metastasis Immunodeficiency or autoimmune disease History of monoclonal antibody allergy Pregnant or breastfeeding women Presence of active infection Patients with mental illness or cognitive impairment

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • China, Hubei Province

    Wuhan, Hubei, 430022, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.