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

NCT06708910 | Recruiting

• 2 other identifiers: 533909315KI 2434/4-1
• Study Type: observational
• Target: 460
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. 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. 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. 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. 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)
7. 7.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
8. 8.Thoracic 18F-FDG PET/MRI including 18F-FDG PET/MRI of the breast after the first two cycles of systemic therapy
9. 9.Thoracic 18F-FDG PET/MRI including 18F-FDG PET/MRI of the breast after completion of systemic therapy and immediately before clinically indicated surgery

Conditions

HER2 Positive Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Response assessment Primary EP

  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

  From enrollment to the end of treatment at 15 weeks

Secondary Outcomes (6)

• Response assessment 1

  From enrollment to the end of treatment at 15 weeks

• Response assessment 2

  From enrollment to the end of treatment at 15 weeks

• Response assessment 3

  From enrollment to the end of treatment at 15 weeks

• Prediction 1

  post baseline staging

• Prediction 2

  3 weeks post NAST start

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: In this study, we aim to enrol biological women with newly diagnosed HER2-positive breast carcinoma.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In this study, we aim to enrol women with newly diagnosed HER2-positive breast carcinoma. For details please see Inclusion/Exclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• previous cancer diagnosis within the last five years or second, synchronous malignancy
• contraindication to MRI examination
• severe renal insufficiency
• pregnancy or lactation

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead
• University Hospital, Essen: collaborator
• Marienhospital Bottrop: collaborator

Study Sites (1)

Department of Diagnostic and Interventional Radiology, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

Central Study Contacts

PD Dr. med. Kirchner

CONTACT

+492118117552; Julian.Kirchner@med.uni-duesseldorf.de

Dr. med. Jannusch

CONTACT

+492118117552; kai.jannusch@med.uni-duesseldorf.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 27, 2024
• Study Start: July 18, 2025
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): July 1, 2031
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)