(S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-CYANO-4,4-DIFLUOROPYRROLIDIN-1-YL)-2-OXOETHYLCARBAMOYL)-QUINOLIN-6-YL)(METHYL)AMINO)-PROPYL)PIPERAZIN-1-YL)-2-OXOETHYL)-68GA-[1,4,7,10]-TETRAAZACYCLODODECANE-1,4,7-TRIYL)TRIACETATE for Ductal carcinoma in situ | Breast cancer

Inclusion criteria

• {"criterion_text":"- Newly diagnosed DCIS with extent in mammography, MRI or ultrasound suspected to range > 4 cm"}
• {"criterion_text":"- Planned DCIS resection (breast conserving or mastectomy) as per guideline recommendation"}
• {"criterion_text":"- Age ≥ 18 years"}
• {"criterion_text":"- Written informed consent"}
• {"criterion_text":"- For women of childbearing potential: confirmed menstrual period (if applicable) and a negative highly sensitive urine or serum pregnancy test"}
• {"criterion_text":"- Women of childbearing potential (WOCBP) and fertile 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."}

Exclusion criteria

• {"criterion_text":"- Contraindications for MRI (specific metallic implants, severe claustrophobia, history of anaphylaxis following MRI contrast agent application)"}
• {"criterion_text":"- GFR < 30 mL/(min∙1.73 m^2)"}
• {"criterion_text":"- Current pregnancy or pregnancy within 8 weeks before begin of study participation"}
• {"criterion_text":"- Current nursing or nursing within 8 weeks before begin of study participation"}
• {"criterion_text":"- Inability to understand the nature, risks, and benefits of the study"}
• {"criterion_text":"- History of diagnosis of ipsilateral invasive breast cancer"}
• {"criterion_text":"- Concurrent diagnosis of contralateral invasive cancer, if not curatively treated by surgery > 1 year ago"}
• {"criterion_text":"- Known hypersensitivity to the active substance or to any of the excipients of the IMP"}

Primary endpoints

• {"endpoint_text":"- Sensitivity based on blinded readers‘ PET/MRI visual assessment score","definition_or_measurement_approach":"Based on blinded readers‘ PET/MRI visual assessment score"}
• {"endpoint_text":"- Specificity based on blinded readers‘ PET/MRI visual assessment score","definition_or_measurement_approach":"Based on blinded readers‘ PET/MRI visual assessment score"}

Secondary endpoints

• {"endpoint_text":"- Optimal threshold and area-under-the-curve of receiver-operating- characteristics curve based on tumor-to-background ratio of SUVmax (60-75min)","definition_or_measurement_approach":"ROC AUC based on tumor-to-background ratio of SUVmax measured at 60-75 min"}
• {"endpoint_text":"- Diagnostic Odds Ratio (DOR) based on Blinded readers’ PET/MRI vs MRI only visual assessment score","definition_or_measurement_approach":"Diagnostic odds ratio comparing blinded readers' PET/MRI versus MRI-only visual assessment scores"}
• {"endpoint_text":"- Sensitivity and specificity of lesion MRI diffusion weighted MRI apparent diffusion coefficient (ADC)","definition_or_measurement_approach":"Sensitivity and specificity based on MRI diffusion-weighted imaging ADC measurements"}
• {"endpoint_text":"- Sensitivity and specificity of the DCE-MRI dynamic feature “Maximal Slope”","definition_or_measurement_approach":"Sensitivity and specificity based on DCE-MRI dynamic feature 'Maximal Slope'"}
• {"endpoint_text":"- Sensitivity and specificity of the DCE-MRI dynamic feature “Bolus arrival time”","definition_or_measurement_approach":"Sensitivity and specificity based on DCE-MRI dynamic feature 'Bolus arrival time'"}
• {"endpoint_text":"- Sensitivity and specificity of the DCE-MRI pharmacokinetic modeling parameter: Volume transfer constant (KTrans)","definition_or_measurement_approach":"Sensitivity and specificity based on DCE-MRI pharmacokinetic parameter KTrans"}
• {"endpoint_text":"- Sensitivity and specificity of the DCE-MRI pharmacokinetic modeling parameter: Fractional plasma volume (Vp)","definition_or_measurement_approach":"Sensitivity and specificity based on DCE-MRI pharmacokinetic parameter Vp"}
• {"endpoint_text":"- Sensitivity and specificity of static PET SUVmax (60-75min)","definition_or_measurement_approach":"Sensitivity and specificity based on static PET SUVmax measured at 60-75 min"}
• {"endpoint_text":"- Sensitivity and specificity of dynamic PET pharmacokinetic modeling parameter binding potential (BP)","definition_or_measurement_approach":"Sensitivity and specificity based on dynamic PET pharmacokinetic binding potential (BP)"}
• {"endpoint_text":"- Number of additional biopsies triggered by PET/MRI visual assessment","definition_or_measurement_approach":"Count of additional biopsies triggered by PET/MRI visual assessment"}
• {"endpoint_text":"- Number of additional biopsies triggered by MRI visual assessment","definition_or_measurement_approach":"Count of additional biopsies triggered by MRI visual assessment"}
• {"endpoint_text":"- Correlation of immunohistopathology FAP visual staining Score with SUVmax (60-75min)","definition_or_measurement_approach":"Correlation analysis between immunohistochemistry FAP visual staining score and SUVmax (60-75 min)"}
• {"endpoint_text":"- Adverse events following [68Ga]Ga-FAPI-46 application","definition_or_measurement_approach":"Adverse events occurring after application of [68Ga]Ga-FAPI-46"}

Germany

Earliest CTIS Part Ii Submission Date

09-04-2024

Latest Decision Or Authorization Date

25-04-2024

Processing Time Days

16

Number Of Sites

2

Number Of Participants

30

Primary sponsor

Full Name

Universitaet Muenster

Organisation Type

Educational Institution

Country Of Registered Address

Germany