Evaluating breast cancer response using advanced imaging techniques
Contrast-enhanced Spectral Mammography (CESM) Early Quantitative Evaluation of Tumoral Response and Pathologic Complete Response Prediction for Localized Breast Cancer Treated by Neoadjuvant Chemotherapy
NA · Hospices Civils de Lyon · NCT06299202
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 35 Years and up |
| Sex | Female |
| Sponsor | Hospices Civils de Lyon (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Lyon) |
| Trial ID | NCT06299202 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women diagnosed with stage II or III localized breast cancer who are set to receive neoadjuvant chemotherapy.
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.
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 performed: Other studies have shown promise with advanced imaging techniques like CESM, suggesting potential for success in this approach.
Eligibility criteria
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 this trial is running
Lyon
- Hôpital de la Croix Rousse — Lyon, France (RECRUITING)
Study contacts
- Study coordinator: Dorothée TACONET, MD
- Email: dorothee.taconet@chu-lyon.fr
- Phone: 0426109185
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Breast cancer, Contrast Enhanced Spectral Mamography, Neodjuvant chemotherapy, Quantitative analysis, Complete histological response