TheranosticTrials.org

Clinical Trial · NCT06540872

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

Overview

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

Sponsor

University of Tennessee

Phase

Phase 2

Contacts

Matthias Burg, Dr. med. (CONTACT)

radiologie@ukmuenster.de

+4925183

Philipp Backhaus, Dr. med. (CONTACT)

nuklearmedizin@ukmuenster.de

+4925183

Philipp Backhaus, Dr. med. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT06540872

Drug / Compound

FAPI-46

Isotope(s):
Target(s):
  • FAP
Ligand Class: Small Molecules
Chelator: DOTA

Eligibility

Inclusion

  • 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.
  • Written informed consent
  • For women of child bearing potential: confirmed menstrual period (if applicable) and a negative highly sensitive urine or serum pregnancy test
  • Planned DCIS resection (breast conserving or mastectomy) as per guideline recommendation
  • * Newly diagnosed DCIS with extent in mammography, MRI or ultrasound suspected to range \> 4 cm

Exclusion

  • * Contraindications for MRI (specific metallic implants, severe claustrophobia, history of anaphylaxis following MRI contrast agent application)
  • Inability to understand the nature, risks, and benefits of the study
  • GFR \< 30 mL/(min∙1.73 m²)
  • Current nursing or within last 8 weeks before begin of study participation
  • Current pregnancy or within last 8 weeks before begin of study participation