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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
[68Ga]Ga-FAPI-46
DrugParticipants 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Single ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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"
Time frame
Within one year after end of trial2
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"
Time frame
Within one year after end of trialSecondary outcomes
1
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)
Time frame
Within one year after end of trial2
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)
Time frame
Within one year after end of trial3
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"
Time frame
Within one year after end of trial4
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)
Time frame
Within one year after end of trialSponsors and contacts
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Source ClinicalTrials.gov