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New scan aims to uncover hidden breast cancer in early stage patients

NCT ID NCT06540872

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a new imaging method called FAPI-PET/MRI to see if it can detect hidden invasive breast cancer in 30 people diagnosed with ductal carcinoma in situ (DCIS), a common pre-stage of breast cancer. Participants receive a weakly radioactive drug and lie in a scanner for about 45 minutes. The results will be compared to tissue samples from surgery to see how accurate the scan is.

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 30 people

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

Started

Feb 2026

Expected to finish

Mar 2028

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

Anyone

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: * Newly diagnosed DCIS with extent in mammography, MRI or ultrasound suspected to range \> 4 cm * Planned DCIS resection (breast conserving or mastectomy) as per guideline recommendation * Written informed consent * For women of child bearing potential: confirmed menstrual period (if applicable) and a negative highly sensitive urine or serum pregnancy test * Women of childbearing potential (WOCBP) and male patients with partners of childbearing/reproductive potential must agree to use highly effective contraception (Pearl index \< 1) when sexually active. This applies for the time period between signing of the informed consent form up to the final trial visit. Exclusion Criteria: * Contraindications for MRI (specific metallic implants, severe claustrophobia, history of anaphylaxis following MRI contrast agent application) * GFR \< 30 mL/(min∙1.73 m²) * Current pregnancy or within last 8 weeks before begin of study participation * Current nursing or within last 8 weeks before begin of study participation * Inability to understand the nature, risks, and benefits of the study * History of diagnosis of ipsilateral invasive breast cancer * Concurrent diagnosis of contralateral invasive cancer, if not curatively treated by surgery \> 1 year ago * Known hypersensitivity to the active substance or to any of the excipients of the Investigational Medicinal Product

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Conditions

The condition(s) this trial relates to.

breast neoplasm ductal breast carcinoma in situ

As listed by the trial registrant

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

Carcinoma, intraductal, noninfiltrating

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. 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

  • Department of Nuclear Medicine, University Hospital Essen

    NOT_YET_RECRUITING

    Essen, North Rhine-Westphalia, 45147, Germany

  • Department of Nuclear Medicine, University Hospital Münster

    RECRUITING

    Münster, North Rhine-Westphalia, 48149, Germany

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