FAPI-PET/MRI to detect hidden invasive cancer in DCIS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial uses [68Ga]Ga-FAPI-46 PET/MRI to look for occult invasive carcinoma in participants with ductal carcinoma in situ (DCIS) who are planning surgical treatment. Participants receive the radiotracer, undergo a 45-minute imaging session, and have a follow-up clinic visit and tests. The goal is to see if FAPI-PET/MRI images correspond to invasive cancer found in surgical tissue samples after removal. The study compares imaging findings with postoperative pathology to determine diagnostic performance. Enrollment is limited to newly diagnosed DCIS with suspected lesion extent and planned resection, with MRI suitability and reproductive considerations addressed.

Why it matters

Who can join: the full rules

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's running

• Department of Nuclear Medicine, University Hospital Münster
  Münster, North Rhine-Westphalia, Germany Recruiting
• Department of Nuclear Medicine, University Hospital Essen
  Essen, North Rhine-Westphalia, Germany Not yet recruiting

Study contacts

• Principal investigator: Philipp Backhaus, Dr. med. — Department of Nuclear Medicine, University Hospital Münster
• Study coordinator: Philipp Backhaus, Dr. med.
• Email: nuklearmedizin@ukmuenster.de
• Phone: +4925183

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.