AI-based pCR Assessment/Prediction in HER2-Positive BC Using PET/MRI
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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 PET/MRI (response assessment) 3. Sensitivity, specificity, and accuracy for the identification of patients with HER2-positive breast carcinoma with complete pathologic remission (pCR) of locoregional lymph node metastases (yN0) after neoadjuvant therapy using 18F-FDG PET/MRI (response assessment) 4. Evaluation of pre-treatment (baseline) 18F-FDG PET/MRI for predicting therapy response of the primary and locoregional lymph node metastases in patients with HER2-positive breast carcinoma supported by artificial-intelligence (prediction) 5. Evaluation of 18F-FDG PET/MRI for predicting therapy response of the primary in patients with HER2-positive breast carcinoma after the first cycles of systemic therapy supported by artificial-intelligence (prediction) 6. Evaluation of 18F-FDG PET/MRI for predicting therapy response of locoregional lymph node metastases in patients with HER2-positive breast carcinoma after the first cycles of system therapy supported by artificial-intelligence (prediction) The guideline-recommended staging procedure (S3 Germany) using CT will be replaced by a whole-body 18F-FDG PET/MRI, including dedicated 18F-FDG PET/MRI of the breast. The histopathologic results of tissue samples obtained during routine clinical treatment after successful neoadjuvant systemic therapy will serve as a reference standard. The study protocol involves the following examinations for all included patients: 1. Baseline (pre-treatment) examination to substitute for the staging examinations specified in the S3 guideline: Initial whole-body 18F-FDG PET/MRI including 18F-FDG PET/MRI of the breast 2. Thoracic 18F-FDG PET/MRI including 18F-FDG PET/MRI of the breast after the first two cycles of systemic therapy 3. Thoracic 18F-FDG PET/MRI including 18F-FDG PET/MRI of the breast after completion of systemic therapy and immediately before clinically indicated surgery
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Pacjentka jest kobietą.
- •Rak piersi jest HER2-dodatni.
- •Pacjentka ma ukończone 18 lat.
- •Pacjentka jest w stanie uczestniczyć w zaplanowanych badaniach.
- •Pacjentka wyraziła pisemną zgodę na udział w badaniu.
- •Pacjentka kwalifikuje się do leczenia neoadiuwantowego (przedoperacyjnego) i nie ma przerzutów odległych.
✗ Disqualifies
- •Pacjentka miała w ciągu ostatnich 5 lat inne rozpoznanie raka lub ma dwa nowotwory jednocześnie.
- •Pacjentka nie może przejść badania rezonansem magnetycznym (MRI).
- •Pacjentka ma poważne problemy z nerkami.
- •Pacjentka jest w ciąży lub karmi piersią.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 24, 2025
- Sex
- Female only
Locations (1)
Department of Diagnostic and Interventional Radiology, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf
Düsseldorf, Germany
Trial contact
PD Dr. med. Kirchner
Dr. med. Jannusch
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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