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

NCT06299202 | Recruiting

• 2 other identifiers: 69HCL23_0204ID-RCB
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Breast cancer; Contrast Enhanced Spectral Mamography; Neodjuvant chemotherapy; Quantitative analysis; Complete histological response

Outcome Measures

Primary Outcomes (1)

• The evolution of the relative tumor enhancement (RTEe) (%) between the baseline and early re-evaluation CESM

  Evolution of the relative tumor enhancement (RTEe) between the baseline and early re-evaluation CESM (4-6 weeks after the start of chemotherapy). That is, the percentage of post-chemo tumor enhancement - Percentage of pre-chemo tumor enhancement / pre-chemo tumor enhancement The relative tumor enhancement (RTE) will be calculated as follows on each CESM (baseline and early follow up): RTE = (ROI 1 - ROI 2) / ROI 2 The evolution of relative tumor enhancement (RTEe) between the initial CESM (RTEi) and the early follow-up CESM (RTEf) will be calculated. RTEe = (RTEf) - (RTEi) / (RTEi)

  At baseline, 2 and 8 months

Secondary Outcomes (2)

• RTEe according to the 3 categories of RCB score

  At 8 months

• The type of enhancement (TE) %

  At baseline and 2 months

Study Arms (1)

Patients with localized breast cancer

EXPERIMENTAL

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

Diagnostic Test: Diagnostic test

Interventions

Diagnostic test 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.

Patients with localized breast cancer

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital de la Croix Rousse

Lyon, 69004, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Dorothée TACONET, MD

CONTACT

0426109185; dorothee.taconet@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 7, 2024
• Study Start: August 23, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

FR (1)