Status:
NOT_YET_RECRUITING
Multimodal Imaging With FAPI-PET/MRI in Breast Carcinoma-In-Situ for Detection of Occult Invasive Cancer
Lead Sponsor:
Universität Münster
Conditions:
Carcinoma, Intraductal, Noninfiltrating
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 diag...
Detailed Description
Ductal carcinoma in situ (DCIS) is a common precursor to breast cancer where abnormal cells are present within the milk ducts without breaking through their walls (in situ). If these cancerous cells h...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06540872
Start Date
September 10 2024
End Date
October 1 2026
Last Update
August 6 2024
Active Locations (2)
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1
Department of Nuclear Medicine, University Hospital Essen
Essen, North Rhine-Westphalia, Germany, 45147
2
Department of Nuclear Medicine, University Hospital Münster
Münster, North Rhine-Westphalia, Germany, 48149