Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New scan technique aims to peek inside breast cancer treatment

NCT ID NCT04861077

Knowledge-focused Sponsor: University of Alabama at Birmingham 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Aug 18, 2026 · Updated 3 times

Summary

This pilot study tests whether a special type of PET/MRI scan can monitor how triple-negative breast cancer responds to immunotherapy. Twenty patients will get three scans over their first two treatment cycles. The results won't change their care but could help design larger studies to improve treatment monitoring.

What this could mean

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

Active substance
[18F]FMISO (a radioactive tracer used in PET scans)
What this could lead to
If successful, this imaging method could help doctors see early on whether immunotherapy is working for triple-negative breast cancer, potentially guiding treatment decisions in larger future trials.
What could go wrong
This is a very early pilot study with only 20 participants, and the scans are not used to change treatment. The results may not apply to all patients or lead to a proven benefit.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 20 people

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

Expected to start

Jun 2027

An estimate. Start dates often move.

Expected to finish

Aug 2030

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 75 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. Patients must be ≥ 18 years old and ≤ 75 years old 2. Triple negative breast cancer (TNBC) patients (biopsy-proven) stage II-IV eligible 3. \>50%Programmed death-ligand 1 (PD-L1) positive 4. Eligible for immunotherapy who are naïve to beginning any immunotherapy treatment 5. May not be pregnant or breastfeeding 6. Subjects must be willing to sign consent 7. Adequate creatinine clearance per institutional guidelines and within 30 days 8. Estimated life expectancy of greater than one year 9. Patients must have one lesion with RECIST measurable disease (greater than 1 cm in diameter, measured from diagnostic breast MRI or staging CT) Exclusion Criteria: 1. Inability to provide informed consent 2. Weight over 350 lbs., due to the scanner bore size 3. Lactating, known or suspected pregnancy. Women with child-bearing potential must a have a negative serum Human chorionic gonadotropin (β-hCG) pregnancy test within 48 hours or a negative urine β-hCG pregnancy test within 24 hours of each PET imaging study. 4. Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos) 5. Unable to lie still on the imaging table for one (1) hour 6. contraindication for gadolinium-based contrast agent, ProHance (gadoteridol) 7. Have received immunotherapy in the neoadjuvant or adjuvant setting

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Triple-negative breast cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

triple-negative breast carcinoma

As listed by the trial registrant

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

Triple-negative 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

  • UAB

    RECRUITING

    Birmingham, Alabama, 35249, United States

More trials for these conditions

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