Multimodal Imaging with FAPI-PET/MRI in Breast Carcinoma-In-Situ for Detection of occult Invasive cancer (MI-CISDIR) - WWU22_0012

niversitaet Muenster0 个研究点目标入组 30 人开始时间: 2024年2月19日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•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, Age = 18 years, Written informed consent, For women of childbearing potential: confirmed menstrual period (if applicable) and a negative highly sensitive urine or serum pregnancy test, Women of childbearing potential (WOCBP) and fertile 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.

•Contraindications for MRI (specific metallic implants, severe claustrophobia, history of anaphylaxis following MRI contrast agent application), GFR < 30 mL/(min·1.73 m^2), Current pregnancy or pregnancy within 8 weeks before begin of study participation, Current nursing or nursing within 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 IMP

发起方

niversitaet Muenster