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New scan could predict breast cancer treatment success in days

NCT ID NCT06086704

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Updated 4 times

Summary

This study tests whether a special PET/MRI scan using a radioactive tracer (18F-FFNP) can detect early signs that hormone therapy is working in breast cancer. About 53 postmenopausal women with a certain type of breast cancer will get the scan before and after taking anastrozole for two weeks. The goal is to see if changes in the scan match changes in tumor activity, which could help doctors personalize treatment faster.

What this could mean

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

Active substance
18F-fluorofuranylnorprogesterone (FFNP) and anastrozole
What this could lead to
If successful, this imaging method could help doctors quickly tell if hormone therapy is working for breast cancer, allowing them to adjust treatment sooner.
What could go wrong
This is a small, early-phase study (53 people) focused on imaging accuracy, not treatment outcomes. The scan may not reliably predict response in all patients.

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 53 people

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

Started

Sep 2024

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 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: * Postmenopausal status defined by either * prior bilateral oophorectomy * age greater than or equal to 60 years of age * age less than 60 years of age and amenorrheic for 12 or more months in the absence of prior chemotherapy, tamoxifen, toremifene or ovarian suppression and FSH and estradiol in the postmenopausal range per local normal range (Group 2 only) * Diagnosis of biopsy-proven invasive breast cancer measuring at least 1.0 cm in diameter by any imaging modality. Malignancy may be located within the breast, axilla (e.g. metastatic axillary lymph node), or both the breast and axilla * Biopsy-proven PR-positive invasive breast cancer * Definitive surgical excision of the primary tumor planned without neoadjuvant therapy; defined as therapy (chemotherapy, targeted therapy, radiation therapy or endocrine therapy) given to decrease the size of the tumor prior to planned surgery. (Group 2 only) Exclusion Criteria: * Inability or unwillingness to provide informed consent to the study * HER2-positive breast cancer, as defined by immunohistochemical staining 3+ OR positive by in situ hybridization (Group 2 only) * PR and Ki67 IHC slides or FFPE tissue blocks from clinical breast biopsy not available * Patients who have completed neoadjuvant chemotherapy, endocrine therapy, targeted therapy, surgical resection, or radiation for the current biopsy-proven malignancy (Group 2 only) * Patients who are planning to undergo anastrozole as standard of care neoadjuvant therapy * Patients who are currently taking aromatase inhibitors or ER antagonists (tamoxifen, raloxifene) * Patients with breast expanders * Patients who are pregnant or lactating * Patients with clinical contraindication for use of aromatase inhibitors (AI) while on study as determined by investigator (Group 2 only) * Patients with a contraindication to gadolinium-based contrast agents, including allergy or impaired renal function (per UW Health Guidelines) * Patients with a history of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-FFNP * Patients with history of allergic reaction to anastrozole (Group 2 only) * Patients in liver failure as judged by the patient's physician * Patients with standard contraindications to MRI (per UW Health Guidelines) * Patients requiring conscious sedation for imaging are not eligible; patients requiring mild, oral anxiolytics for the clinical MRI scan will be allowed to participate as long as the following criteria are met: * The patient has their own prescription for the medication * The informed consent process is conducted prior to the self-administration of the medication. * The patient comes to the research visit with a driver. * Patients unable to lie prone for 45 minutes for imaging

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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 study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • UW Carbone Cancer Center

    RECRUITING

    Madison, Wisconsin, 53792, United States

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