Ignite Creation Date:
2024-07-17 @ 10:52 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498388
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-06-03
Brief Title:
Predicting Breast Cancer With the BRAVE System
Sponsor:
Université de Sherbrooke
Organization:
Université de Sherbrooke
Study Overview
Official Title:
Building the Predictive Model of the BRA-based ViscoElastography BRAVE System for Detecting Breast Cancer Tumors BRAVE Discovery Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
BRAVE
Brief Summary:
Breast cancer predominates among cancer diagnoses in Canadian women It accounts for around 25 of new cases and contributes to 13 of all cancer-related deaths In 2020 almost 27400 Canadian women were diagnosed with breast cancer and 5000 of them died from it
Mammography is still the preferred method for screening for breast cancer Although progress has been made over the years mammography does have its drawbacks These include physical discomfort for patients exposure to X-rays and reduced effectiveness in dense breasts The study team is therefore interested in developing a new breast cancer detection method the BRAVE method
The BRAVE method short for BRA-based Visco-Elastography uses the high contrast of elastic stiffness in malignant breast tumors to detect possible cancer cases without the need for X-rays or breast compression
The first phase carried out on a small scale pilot study aimed to assess the methods ability to distinguish a breast with no abnormalities from one with confirmed cancer The second phase current phase carried out on a larger scale aims to confirm the sensitivity and specificity of the method in detecting malignant lesions ie to determine whether the method is capable of distinguishing between several types of breast masses
Mammography is still the preferred method for screening for breast cancer Although progress has been made over the years mammography does have its drawbacks These include physical discomfort for patients exposure to X-rays and reduced effectiveness in dense breasts The study team is therefore interested in developing a new breast cancer detection method the BRAVE method
The BRAVE method short for BRA-based Visco-Elastography uses the high contrast of elastic stiffness in malignant breast tumors to detect possible cancer cases without the need for X-rays or breast compression
The first phase carried out on a small scale pilot study aimed to assess the methods ability to distinguish a breast with no abnormalities from one with confirmed cancer The second phase current phase carried out on a larger scale aims to confirm the sensitivity and specificity of the method in detecting malignant lesions ie to determine whether the method is capable of distinguishing between several types of breast masses
Detailed Description:
This study has two objectives which will be studied in two separate groups
1 To measure the sensitivity and specificity of BRAVE in identifying malignant lesions in a cohort of 300 women
2 To assess the impact of breast density on the ability of BRAVE to discriminate malignant breast lesions
The research team aim to recruit 300 women requiring follow-up imaging Half will have lower breast density categories A or B and the other half will have higher breast density categories C or D
Participants will need to attend a single visit lasting approximately 75 minutes where they will be asked to wear the studys bra and complete the examination process
Other data will also be collected in the medical file to enable the team to confirm the density of the breast and the results and dates of mammography imaging or other tests related to breast cancer
1 To measure the sensitivity and specificity of BRAVE in identifying malignant lesions in a cohort of 300 women
2 To assess the impact of breast density on the ability of BRAVE to discriminate malignant breast lesions
The research team aim to recruit 300 women requiring follow-up imaging Half will have lower breast density categories A or B and the other half will have higher breast density categories C or D
Participants will need to attend a single visit lasting approximately 75 minutes where they will be asked to wear the studys bra and complete the examination process
Other data will also be collected in the medical file to enable the team to confirm the density of the breast and the results and dates of mammography imaging or other tests related to breast cancer
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