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

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

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

Conditions3

Interventions1

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