AI-based pCR Assessment/Prediction in HER2-Positive BC Using PET/MRI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: HER2 Positive Breast Carcinoma. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multiparametric 18F-FDG PET/MRI for Assessment and Prediction of Locoregional Therapy Response in HER2-positive Breast Cancer Patients Using Artificial Intelligence
Overview
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
Primary outcome measures
- Response assessment Primary EP [Time frame: From enrollment to the end of treatment at 15 weeks]
Secondary outcome measures (6)
- Response assessment 1 [Time frame: From enrollment to the end of treatment at 15 weeks]
- Response assessment 2 [Time frame: From enrollment to the end of treatment at 15 weeks]
- Response assessment 3 [Time frame: From enrollment to the end of treatment at 15 weeks]
- Prediction 1 [Time frame: post baseline staging]
- Prediction 2 [Time frame: 3 weeks post NAST start]
- Prediction 3 [Time frame: 3 weeks post NAST start]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Department of Diagnostic and Interventional Radiology, Medical Faculty and University Hosp — Düsseldorf
Identifiers
NCT: NCT06708910 · 533909315 · KI 2434/4-1