Multimodal Imaging With FAPI-PET/MRI in Breast Carcinoma-In-Situ for Detection of Occult Invasive Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversität Münster
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- [68Ga]Ga-FAPI-46
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov