RecruitingNot ApplicableNCT06299202

Contrast-enhanced Spectral Mammography (CESM) Early Quantitative Evaluation of Tumoral Response and Pathologic Complete Response Prediction for Localized Breast Cancer Treated by Neoadjuvant Chemotherapy


Sponsor

Hospices Civils de Lyon

Enrollment

100 participants

Start Date

Aug 23, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Some types of localised breast cancer, including stage II and III, HER2 positive (Human Epidermal Growth Factor Receptor) or triple negative cancers are treated with primary or neoadjuvant chemotherapy prior to surgical treatment (mastectomy or conservative treatment). Follow-up with neoadjuvant or primary chemotherapy is usually done by breast Magnetic Resonance Imaging (MRI).Tumour response to treatment is assessed on morphological size criteria. Angiomammography (also called CESM : Contrast Enhanced Spectral Mammography) is an innovative and validated imaging technique consisting of dual energy mammography with injection of iodinated contrast medium; two images are generated, one comparable to a standard mammography and a second image highlighting the structures enhanced by the contrast medium. The characteristic neo angiogenesis of the tumour process thus allows good visualisation of the tumour compared to the underlying mammary gland. A classical morphological analysis is therefore possible thanks to standard mammographic acquisition coupled with a quantitative functional analysis linked to the study of enhancement. During angiomammography, several images are acquired in succession, starting with the cranio caudal view and ending with the profile view. On the same examination, these acquisitions are carried out at different injection times, making it possible to study the type of enhancement of a given area (Progressive/ Plateau/ Wash out). Angiomammography has several advantages over breast MRI in the follow-up of chemotherapy: shorter examination time, shorter appointment time, better tolerated by the patients and without injection of Gadolinium chelates, which have recently been shown to cause definitive brain deposits during repeated injections. Currently, angiomammography is validated in the follow-up of breast cancers treated with neoadjuvant or primary chemotherapy, with an analysis of tumour response currently only morphological, as in breast MRI. Here, the hypothesis is that the study of tumour enhancement by angiomammography may constitute a new predictive element of histological response: indeed, the performance of an initial angiomammography before treatment (baseline) and then a second angiomammography performed early in relation to the start of chemotherapy, could allow early prediction of which patients will have a complete histological response at the time of the closing surgery. This prospective study is to compare the variation in tumour enhancement, assessed on each of the two examinations using dedicated X-ray consoles, to the final histological result after closure surgery: it is hoped that the relative variation in tumour enhancement would be greater in responding patients.


Eligibility

Sex: FEMALEMin Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether contrast-enhanced spectral mammography (CESM) — a specialized type of mammogram that uses an injected contrast dye to highlight active tumor areas — can predict how well breast cancer responds to chemotherapy given before surgery. **You may be eligible if...** - You have been diagnosed with Stage II or III breast cancer that is either HER2-positive or triple-negative - You are scheduled to receive chemotherapy before surgery (neoadjuvant chemotherapy) - You are covered by a French social security scheme and have signed informed consent **You may NOT be eligible if...** - You are pregnant or breastfeeding - You are allergic to iodinated contrast material or have kidney disease with low filtration rate (below 35 ml/min) - You have a known very high genetic risk (BRCA1/2 mutation, Li-Fraumeni syndrome, Lynch syndrome, or prior chest radiation for lymphoma) - You do not speak French - You are participating in another research study with a current exclusion period - You are under legal protection (guardianship or curatorship) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTDiagnostic test

* Inclusion visit (V1) Initial baseline CESM (V2) 15 days after inclusion * First chemotherapy treatment (V3) 28 days after V2. * Unilateral follow-up CESM (V4) 4 to 6 weeks after the first course of chemotherapy. * Surgery (V5): 3 to 6 weeks later at the end of the complete treatment with primary chemotherapy * End of research visit (V6) It corresponds to the histological analysis on the surgical specimen after the complete treatment with neoadjuvant or primary chemotherapy.


Locations(1)

Hôpital de la Croix Rousse

Lyon, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06299202


Related Trials