Multimodal Imaging With FAPI-PET/MRI in Breast Carcinoma-In-Situ for Detection of Occult Invasive Cancer

Recruiting now · Phase 2

Conditions studied: Carcinoma, Intraductal, Noninfiltrating

In brief

DCIS (ductal carcinoma in situ) is a common pre-stage for breast cancer. The goal of this clinical trial is to learn if FAPI-PET/MRI (an imaging technique with a weakly radioactive drug) helps to diagnose hidden invasive breast cancer in participants with DCIS. The main question it aims to answer is: How good can FAPI-PET/MRI diagnose hidden invasive breast cancer in DCIS? Researchers will compare FAPI-PET/MRI results to tissue samples obtained from surgery treatment to see if the FAPI-PET/MRI images show invasive breast cancer certainly. Participants will * receive the radioactive drug and lie in an imaging device for 45 minutes including a break * visit the clinic once again for a checkup and test

Key facts

Study ID

NCT06540872

Run by

Universität Münster

People needed

30

Starts

2026-02-20

Expected to finish

2028-03-01

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Department of Nuclear Medicine, University Hospital Münster — Münster, North Rhine-Westphalia, Germany (enrolling)
• Department of Nuclear Medicine, University Hospital Essen — Essen, North Rhine-Westphalia, Germany

Full record on ClinicalTrials.gov

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