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

NCT ID: NCT06299202

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-23
• Study Completion Date: 2027-05-31

Brief 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with localized breast cancer

Patients with localized breast cancer (stage II or III, HER 2, triple-negative) eligible for a neoadjuvant chemotherapy and not presenting contraindication to angiomammography.

Group Type: EXPERIMENTAL

Diagnostic test

Intervention Type: DIAGNOSTIC_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.

Interventions

Diagnostic 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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

• Minimum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital de la Croix Rousse

Lyon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Dorothée TACONET, MD

Role: CONTACT

dorothee.taconet@chu-lyon.fr

0426109185 ext. +33

Facility Contacts

Dorothée TACONET, MD

Role: primary

dorothee.taconet@chu-lyon.fr

0426109185 ext. +33

Other Identifiers

ID-RCB

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL23_0204

Identifier Type: -

Identifier Source: org_study_id