Using PET/MRI and AI to predict complete tumor response in HER2‑positive breast cancer
Official title: Multiparametric 18F-FDG PET/MRI for Assessment and Prediction of Locoregional Therapy Response in HER2-positive Breast Cancer Patients Using Artificial Intelligence
Run by Heinrich-Heine University, Duesseldorf · NCT06708910 · Data updated 2026-11-12
This study will test whether PET/MRI scans combined with artificial intelligence can tell which women with HER2‑positive breast cancer have no remaining tumor after neoadjuvant therapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 460 (estimated) |
| Sponsor | Heinrich-Heine University, Duesseldorf Academic / other |
| Locations | 1 site (Düsseldorf, North Rhine-Westphalia) |
| Status | Recruiting |
| Started | July 18, 2025 |
| Main results expected | March 2031 |
| Study ends | July 2031 |
| Registry record updated | September 24, 2025 |
| Trial ID | NCT06708910 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult (≥18) women with confirmed HER2‑positive breast cancer who are willing to undergo PET/MRI scans, have agreed to neoadjuvant systemic therapy, and can give informed consent are ideal candidates.
✕Probably not a fit
Patients who are pregnant or breastfeeding, have severe renal insufficiency, have contraindications to MRI, have recent or synchronous other cancers, or have distant metastases are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study collects 18F‑FDG PET/MRI scans from women with HER2‑positive breast cancer who are planned for or receiving neoadjuvant systemic therapy and compares imaging-based AI predictions to surgical pathology. The primary co-endpoints are sensitivity and specificity for identifying pathological complete response (pCR; yT0 yN0). Secondary endpoints include accuracy and separate performance measures for primary-tumor pCR (yT0) and overall pCR. No investigational drugs are given; the study focuses on image acquisition, AI analysis, and correlation with standard pathological results.
Why it matters
Potential benefit: If successful, the approach could help identify patients with complete response noninvasively and support more personalized surgical or treatment planning.
How similar studies have gone: Previous smaller studies combining PET/MRI and machine‑learning methods have produced promising but not yet definitive results, so the approach remains emerging.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Department of Diagnostic and Interventional Radiology, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf
Düsseldorf, North Rhine-Westphalia, Germany Recruiting
Study contacts
- Study coordinator: PD Dr. med. Kirchner
- Email: Julian.Kirchner@med.uni-duesseldorf.de
- Phone: +492118117552
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.