Evaluating breast cancer response using advanced imaging techniques
Official title: Contrast-enhanced Spectral Mammography (CESM) Early Quantitative Evaluation of Tumoral Response and Pathologic Complete Response Prediction for Localized Breast Cancer Treated by Neoadjuvant Chemotherapy
Run by Hospices Civils de Lyon · NCT06299202 · Data updated 2026-11-12
This study is testing if a new imaging technique called CESM can better show how well chemotherapy is working for patients with stage II and III HER2 positive or triple-negative breast cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 35 Years and up |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Lyon) |
| Status | Recruiting |
| Started | August 23, 2024 |
| Main results expected | May 2027 |
| Study ends | May 2027 |
| Registry record updated | September 27, 2024 |
| Trial ID | NCT06299202 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women diagnosed with stage II or III localized breast cancer who are set to receive neoadjuvant chemotherapy.
✕Probably not a fit
Patients with very high genetic risk for breast cancer or those who cannot receive iodinated contrast material may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of Contrast Enhanced Spectral Mammography (CESM) in assessing the response of localized breast cancer to neoadjuvant chemotherapy. It focuses on patients with stage II and III HER2 positive or triple-negative breast cancer, utilizing CESM to visualize tumor characteristics enhanced by contrast medium. The goal is to improve the prediction of pathologic complete response compared to traditional MRI methods. Participants will undergo CESM imaging to evaluate their tumor response during treatment.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate assessments of treatment response in breast cancer patients, potentially improving treatment outcomes.
How similar studies have gone: Other studies have shown promise with advanced imaging techniques like CESM, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * With a histological diagnosis of stage II or III localised breast cancer, with an indication for first or neoadjuvant chemotherapy validated by the RCP: HER2+, Triple negative * Affiliated or beneficiary of a social security scheme or similar * Having signed an informed consent for participation in the study. Exclusion Criteria: * Patients considered to be at very high risk (BRCA 1 and 2 mutation, Li Fraumeni syndrome, Lynch syndrome, previous thoracic irradiation for lymphoma) and high genetic risk as determined by an oncogenetic consultation * Pregnancy, breastfeeding * Contraindication to the injection of iodinated contrast material: hypersensitivity to the active substance or to one of the excipients of the contrast material, renal insufficiency with glomerular filtration rate \< 35ml/min * Patients who do not master the French language * Patient who is an adult protected by law, under curatorship or guardianship * Patient who has participated in another research study with a current exclusion period
Where it's running
-
Hôpital de la Croix Rousse
Lyon, France Recruiting
Study contacts
- Study coordinator: Dorothée TACONET, MD
- Email: dorothee.taconet@chu-lyon.fr
- Phone: 0426109185
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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.