Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06299202
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-02-19
Brief 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
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CERePred
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 MRITumour 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
Follow-up with neoadjuvant or primary chemotherapy is usually done by breast Magnetic Resonance Imaging MRITumour 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ID-RCB | OTHER | 2023-A01905-40 | None |