Multimodal Imaging With FAPI-PET/MRI in Breast Carcinoma-In-Situ for Detection of Occult Invasive Cancer
NCT Number: NCT06540872
Acronym: MI-CISDIR
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Carcinoma, Intraductal, Noninfiltrating
Interventions: DRUG: [68Ga]Ga-FAPI-46
Sponsor: Universität Münster
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09-10
Completion Date: 2026-10
Locations: Department of Nuclear Medicine, University Hospital Essen, Essen, NRW, 45147, Germany|Department of Nuclear Medicine, University Hospital Münster, Münster, NRW, 48149, Germany

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

Primary Outcome Measures: Evaluation of feasibility of detection of occult invasive cancer in diagnosed DCIS of [68Ga]Ga-FAPI-46 breast PET/MRI, Sensitivity based on blinded readers' PET/MRI visual assessment: "Suspicious for occult carcinoma: Yes/No", Within one year after end of trial|Evaluation of feasibility of detection of occult invasive cancer in diagnosed DCIS of [68Ga]Ga-FAPI-46 breast PET/MRI, Specificity based on blinded readers' PET/MRI visual assessment: "Suspicious for occult carcinoma: Yes/No", Within one year after end of trial
Secondary Outcome Measures: Evaluation of feasibility of detection of occult invasive cancer in diagnosed DCIS of [68Ga]Ga-FAPI-46 breast PET/MRI, Optimal threshold based on tumor-to-background ratio of SUVmax (60-75min), Within one year after end of trial|Evaluation of feasibility of detection of occult invasive cancer in diagnosed DCIS of [68Ga]Ga-FAPI-46 breast PET/MRI, Area-under-the-curve of receiver-operating-characteristics curve based on tumor-to-background ratio of SUVmax (60-75min), Within one year after end of trial|Diagnostic Odds Ratio (DOR) to evaluate possible superiority of PET/MRI visual assessment over breast MRI alone, Based on Blinded readers' PET/MRI vs MRI only visual assessment: "Suspicious for occult carcinoma: Yes/No", Within one year after end of trial|Evaluate the added value for diagnostic performance of MRI measures of diffusibility, Sensitivity and specificity of lesion MRI diffusion weighted MRI apparent diffusion coefficient (ADC), Within one year after end of trial|Evaluate the added value for diagnostic performance of MRI measures of perfusion and permeability, Sensitivity and specificity of the DCE-MRI dynamic feature "Maximal Slope", Within one year after end of trial|Evaluate the added value for diagnostic performance of MRI measures of perfusion and permeability, Sensitivity and specificity of the DCE-MRI dynamic feature "Bolus arrival time", Within one year after end of trial|Evaluate the added value for diagnostic performance of MRI measures of perfusion and permeability, Sensitivity and specificity of the DCE-MRI pharmacokinetic modeling parameter: Volume transfer constant (KTrans), Within one year after end of trial|Evaluate the added value for diagnostic performance of MRI measures of perfusion and permeability, Sensitivity and specificity of the DCE-MRI pharmacokinetic modeling parameter: Fractional plasma volume (Vp), Within one year after end of trial|Evaluate the diagnostic performance of the PET parameter SUVmax (60-75min), Sensitivity and specificity of static PET SUVmax (60-75min), Within one year after end of trial|Evaluate the diagnostic performance of PET pharmacokinetic modeling parameters, Sensitivity and specificity of dynamic PET pharmacokinetic modeling parameter binding potential (BP), Within one year after end of trial|Evaluate impact of PET/MRI on follow-up minimal invasive diagnostic procedures, Number of additional biopsies triggered by PET/MRI visual assessment, Within one year after end of trial|Evaluate impact of MRI on follow-up minimal invasive diagnostic procedures, Number of additional biopsies triggered by MRI visual assessment, Within one year after end of trial|Evaluate the correspondence of FAP-expression determined by immunohistochemistry and PET, Correlation of immunohistopathology FAP visual staining score with SUVmax (60-75min), Joint analysis of the collected samples after the end of the trial. Samples were collected during regular surgery after the final trial visit.|Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], Adverse events following \[68Ga\]Ga-FAPI-46 application, Day of trial medication application and final visit (5-21 days after drug receival)