Clinical trial NCT06708910: AI-based PCR Assessment/Prediction in HER2-Positive BC Using PET/MRI
Official title: Multiparametric 18F-FDG PET/MRI for Assessment and Prediction of Locoregional Therapy Response in HER2-positive Breast Cancer Patients Using Artificial Intelligence
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: HER2 Positive Breast Carcinoma
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: University Hospital, Essen
name: Marienhospital Bottrop
First posted: 2024-11-27
Enrollment: 460
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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. 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


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

Primary outcomes:
measure: Response assessment Primary EP
timeFrame: From enrollment to the end of treatment at 15 weeks
Secondary outcomes:
measure: Response assessment 1
timeFrame: From enrollment to the end of treatment at 15 weeks
measure: Response assessment 2
timeFrame: From enrollment to the end of treatment at 15 weeks
measure: Response assessment 3
timeFrame: From enrollment to the end of treatment at 15 weeks
measure: Prediction 1
timeFrame: post baseline staging
measure: Prediction 2
timeFrame: 3 weeks post NAST start
measure: Prediction 3
timeFrame: 3 weeks post NAST start
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Department of Diagnostic and Interventional Radiology, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf
state: NRW
Study officials:
References: