Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06247449
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2024-01-25
Brief Title:
MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2 Stage II or III Breast Cancer
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2 Stage II or III Breast Cancer A Multi-centre Prospective Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-01
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:
None
Brief Summary:
The goal of this multi-centre prospective study is to assess the frequency of asymptomatic brain metastasis in patients with stage II or III Triple Negative or HER2 positive breast cancer The main questions it aims to answer are
1 What proportion of patients with stage II or III Triple Negative or HER2 positive breast cancer have asymptomatic brain metastases identified on a screening contrast-enhanced magnetic resonance imaging or computed tomography when Magnetic resonance is not possible of the brain
2 How do patients feel about undergoing brain imaging to screen for asymptomatic Brain metastasis
3 What clinical and tissue-based biomarkers are associated with asymptomatic detection of Brain metastasis
Participants will undergo a brain imaging collect one blood sample to perform ctDNA analysis and fill the Testing Morbidities Index TMI after imaging is done Procedures must take place within one year of initial diagnosis either prior to or after completion of neo-adjuvant systemic therapy
1 What proportion of patients with stage II or III Triple Negative or HER2 positive breast cancer have asymptomatic brain metastases identified on a screening contrast-enhanced magnetic resonance imaging or computed tomography when Magnetic resonance is not possible of the brain
2 How do patients feel about undergoing brain imaging to screen for asymptomatic Brain metastasis
3 What clinical and tissue-based biomarkers are associated with asymptomatic detection of Brain metastasis
Participants will undergo a brain imaging collect one blood sample to perform ctDNA analysis and fill the Testing Morbidities Index TMI after imaging is done Procedures must take place within one year of initial diagnosis either prior to or after completion of neo-adjuvant systemic therapy
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