Multimodal Imaging With FAPI-PET/MRI in Breast Carcinoma-In-Situ for Detection of Occult Invasive Cancer
Recruiting · NCT06540872 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
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
Where it is running
2 locations listed.
- Department of Nuclear Medicine, University Hospital Essen - Essen, North Rhine-Westphalia, Germany
- Department of Nuclear Medicine, University Hospital Münster - Münster, North Rhine-Westphalia, Germany