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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Germany
Department of Nuclear Medicine, University Hospital Essen
NOT_YET_RECRUITING
Essen
Department of Nuclear Medicine, University Hospital Münster
RECRUITING
Münster
Contact Information
Primary
Philipp Backhaus, Dr. med.
nuklearmedizin@ukmuenster.de
+4925183
Backup
Matthias Burg, Dr. med.
radiologie@ukmuenster.de
+4925183
Time Frame
Start Date: 2026-02-20
Estimated Completion Date: 2028-03
Participants
Target number of participants: 30
Treatments
Experimental: Single Arm
All participants receive the drug \[68Ga\]Ga-FAPI-46 and imaging
Related Therapeutic Areas
Sponsors
Leads: Universität Münster

This content was sourced from clinicaltrials.gov