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New scan technique aims to personalize breast cancer therapy

NCT ID NCT07419867

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether special PET/MRI scans can predict how well breast cancer treatments work. 300 women will get scans before and after two cycles of therapy. The goal is to find which scan patterns match good or poor responses, helping doctors choose the right treatment for each patient in the future.

What this could mean

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

Active substance
PET/MRI scans with specific tracers (18F-FDG, HER2, FAPI)
What this could lead to
If successful, this could help doctors predict which breast cancer treatments work best for each patient, personalizing care.
What could go wrong
This is an early, exploratory phase II trial. It is designed to gather information, not to prove a treatment works. The results may not lead to immediate changes in care.

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 300 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

Jan 2032

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 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: 1. Female patients aged 18 to 70 years. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 3. Histologically confirmed invasive breast cancer. 4. Known ER, PR and HER2 status. 5. At least one measurable lesion according to RECIST 1.1. 6. Adequate organ function, meeting all of the following: * Hemoglobin (Hb)≥90 g/L; * Absolute neutrophil count (ANC)≥1.5×10\^9/L; * Platelet count (PLT)≥100×10\^9/L; * Total bilirubin (TBIL)≤1.5×the upper limit of normal (ULN); * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5×ULN; * Alkaline phosphatase (ALP)≤2.5×ULN; * Serum creatinine (Cr)≤1.5×ULN; * Prothrombin time (PT) and activated partial thromboplastin time (APTT)≤1.5×ULN, and international normalized ratio (INR)≤1.5×ULN (in patients not receiving anticoagulation). 7. Left ventricular ejection fraction (LVEF)≥55% at baseline as measured by echocardiography or multi-gated acquisition (MUGA) scan. 8. Women of childbearing potential must have a negative serum pregnancy test. Such patients must use a medically acceptable method of contraception during study treatment and for at least 6 months after the last dose of the study drug(s). 9. The subject voluntarily agrees to participate, signs the informed consent form, has good compliance, and is willing to adhere to follow-up. Exclusion Criteria: 1. Any other malignancy within the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer. 2. Diabetics or those allergic to radionuclides who are not suitable for 18F-FDG PET/MR examination. 3. Serious cardiovascular or cerebrovascular disease within 6 months prior to randomization, including but not limited to congestive heart failure, unstable angina, severe arrhythmias uncontrolled by medication, severe conduction abnormalities or clinically significant valvular disease, uncontrolled severe hypertension, myocardial infarction, or cerebrovascular accident. 4. Any serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \[e.g. estimated creatinine clearance \<30ml/min\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea). 5. Major surgery within 4 weeks prior to randomization without full recovery, or an anticipated need for major surgery during study treatment. 6. Known active liver disease, including but not limited to active hepatitis B (defined as HBsAg positive with HBV-DNA≥1000 IU/mL), hepatitis C (defined as HCV-Ab positive with HCV-RNA above the assay's lower limit of quantification), or autoimmune liver disease. 7. Severe and uncontrolled infection or known HIV infection. 8. Active systemic bacterial infection (requiring intravenous antibiotics at time of initiating study treatment) or fungal infection. 9. Pregnant or breastfeeding. 10. Known allergy to the study drug or any of its excipients, or a history of severe hypersensitivity reactions to other monoclonal antibodies. 11. Known abuse of psychotropic substances, alcoholism, or drug abuse. 12. Known, definite neurological or psychiatric disorders associated with poor compliance, including but not limited to epilepsy or dementia. 13. Any other serious physical or mental illness or laboratory abnormality that may increase the risk of study participation or interfere with study treatment and outcomes, or any other condition that, in the investigator's judgment, makes the patient unsuitable for this study. 14. Receiving radiotherapy (except for palliative reasons), chemotherapy and immunotherapy within 3 weeks before treatment, excluding bisphosphonates (can be used for bone metastasis).

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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.

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

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032, China

More trials for these conditions

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