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

NCT06540872 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-08-06

No results posted yet for this study

Summary

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

Conditions

  • Carcinoma, Intraductal, Noninfiltrating

Interventions

DRUG

[68Ga]Ga-FAPI-46

Participants receive the weakly radioactive drug \[68Ga\]Ga-FAPI-46 through their vein and lie in an imaging device (PET/MRI) for 30 minutes. After a break of 30 minutes, they will lie in the imaging device for another 15 minutes.

Sponsors & Collaborators

  • Universität Münster

    lead OTHER

Principal Investigators

  • Philipp Backhaus, Dr. med. · Department of Nuclear Medicine, University Hospital Münster

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-10
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06540872 on ClinicalTrials.gov