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AI-based pCR Assessment/Prediction in HER2-Positive BC Using PET/MRI

Recruitingn/aAges 18 Years - anyFemaleHeinrich-Heine University, Duesseldorf
NCT06708910 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Goal of the observational study: Based on PET/MRI data it is possible to differentiate between complete and incomplete pathological remission after neoadjuvant systemic therapy in HER2-positive breast cancer patients. The main question it aims to answer are: Primary endpoint: 1\) Sensitivity and specificity as co-primary endpoints for identification of HER2-positive breast carcinoma with complete pathologic remission (pCR; yT0 yN0) using 18F-FDG PET/MRI (response assessment) Secondary endpoint(s): 1. Accuracy for the identification of patients with HER2-positive breast carcinoma with complete pathologic remission (pCR; yT0 yN0) using 18F-FDG PET/MRI (response assessment) 2. Sensitivity, specificity, and accuracy for the identification of patients with HER2-positive breast carcinoma with complete pathologic remission (pCR) of the primary (yT0) after neoadjuvant therapy using 18F-FDG

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📋 Eligibility rules (as published)
Inclusion Criteria: * Female * HER2-positive breast carcinoma * legally competent female patients aged ≥ 18 years * willing and able to attend scheduled examinations * written informed consent for study participation * decision to receive neoadjuvant systemic therapy / exclusion of distant metastases Exclusion Criteria: * previous cancer diagnosis within the last five years or second, synchronous malignancy * contraindication to MRI examination * severe renal insufficiency * pregnancy or lactation
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What it tests

  • Not listed
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Where

1 site
Department of Diagnostic and Interventional Radiology, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf
Düsseldorf, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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