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

September 23, 2025 updated by: Heinrich-Heine University, Duesseldorf

Multiparametric 18F-FDG PET/MRI for Assessment and Prediction of Locoregional Therapy Response in HER2-positive Breast Cancer Patients Using Artificial Intelligence

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):

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)
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)
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)
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)
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)
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:

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

Study Overview

Status

Recruiting

Conditions

HER2 Positive Breast Carcinoma

Study Type

Observational

Enrollment (Estimated)

460

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: PD Dr. med. Kirchner
Phone Number: +492118117552
Email: Julian.Kirchner@med.uni-duesseldorf.de

Study Contact Backup

Name: Dr. med. Jannusch
Phone Number: +492118117552
Email: kai.jannusch@med.uni-duesseldorf.de

Study Locations

Germany
- North Rhine-Westphalia
  - Düsseldorf, North Rhine-Westphalia, Germany, 40225
    - Recruiting
    - Department of Diagnostic and Interventional Radiology, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response assessment Primary EP Time Frame: From enrollment to the end of treatment at 15 weeks	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response assessment 1 Time Frame: From enrollment to the end of treatment at 15 weeks	Accuracy for the identification of patients with 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
Response assessment 2 Time Frame: From enrollment to the end of treatment at 15 weeks	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	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	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	From enrollment to the end of treatment at 15 weeks
Prediction 1 Time Frame: post baseline staging	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	post baseline staging
Prediction 2 Time Frame: 3 weeks post NAST start	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	3 weeks post NAST start
Prediction 3 Time Frame: 3 weeks post NAST start	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	3 weeks post NAST start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Collaborators

University Hospital, Essen

Marienhospital Bottrop

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2025

Primary Completion (Estimated)

March 1, 2031

Study Completion (Estimated)

July 1, 2031

Study Registration Dates

First Submitted

November 25, 2024

First Submitted That Met QC Criteria