AI-based pCR Assessment/Prediction in HER2-Positive BC Using PET/MRI
NCT ID: NCT06708910
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
460 participants
OBSERVATIONAL
2025-07-18
2031-07-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* contraindication to MRI examination
* severe renal insufficiency
* pregnancy or lactation
18 Years
FEMALE
No
Sponsors
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University Hospital, Essen
OTHER
Marienhospital Bottrop
UNKNOWN
Heinrich-Heine University, Duesseldorf
OTHER
Responsible Party
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Locations
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Department of Diagnostic and Interventional Radiology, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf
Düsseldorf, North Rhine-Westphalia, Germany
Countries
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Central Contacts
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Other Identifiers
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KI 2434/4-1
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
533909315
Identifier Type: -
Identifier Source: org_study_id
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