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

RecruitingPhase 2Ages 18 Years - anyAllUniversität Münster
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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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What it tests

  • [68Ga]Ga-FAPI-46
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Where

2 sites
Department of Nuclear Medicine, University Hospital Essen
Essen, Germany
Department of Nuclear Medicine, University Hospital Münster
Münster, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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