Multimodal Imaging With FAPI-PET/MRI in Breast Carcinoma-In-Situ for Detection of Occult I
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-
| Condition(s) | Carcinoma, Intraductal, Noninfiltrating |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Universität Münster |
| Locations | Essen, North Rhine-Westphalia, Germany; Münster, North Rhine-Westphalia, Germany |
| Start date | 2026-02-20 |
| NCT ID | NCT06540872 |
| Official listing | https://clinicaltrials.gov/study/NCT06540872 |