To hear about similar clinical trials, please enter your email below
Trial Title:
MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2+ Stage II or III Breast Cancer
NCT ID:
NCT06247449
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Neoplasm Metastasis
Brain Neoplasms
Conditions: Keywords:
HER2
Triple Negative
Brain Metastasis
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Brain imaging
Description:
Brain Magnetic resonance (or computed tomography if magnetic resonance is
contraindicated)
Arm group label:
Screening MRI
Intervention type:
Diagnostic Test
Intervention name:
Analysis of circulating tumor DNA
Description:
One single blood draw for analysis of circulating tumor DNA
Arm group label:
Screening MRI
Intervention type:
Behavioral
Intervention name:
Testing Morbidities Index
Description:
Questionnaire regarding the participant's perception of brain imaging.
Arm group label:
Screening MRI
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age > 18.
2. Triple Negative OR HER2+ breast cancer (as per 2018 ASCO/CAP guidelines).
3. Stage II or III disease.
4. Patients with a prior or concurrent malignancy whose natural history or treatment
does not have the potential to interfere with the safety or efficacy assessment of
the investigational regimen may participate.
5. Ability to understand and the willingness to sign a written informed consent
document.
Exclusion Criteria:
1. Creatinine clearance <30 mL/min using the Cockcroft-Gault equation (in accordance
with the product monograph for Gadavist IV contrast.
2. Pregnant women are not permitted to participate given that the safety of IV contrast
is unknown in this population.
3. Patients with central nervous system symptoms that are concerning for brain
metastases that would otherwise be referred for brain imaging.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sunnybrook Health Science Centre
Address:
City:
Toronto
Zip:
M4N 3M5
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Katarzyna Jerzak, MD M.Sc
Phone:
416-480-6100
Phone ext:
5248
Email:
katarzyna.jerzak@sunnybrook.ca
Start date:
November 29, 2023
Completion date:
June 1, 2028
Lead sponsor:
Agency:
Sunnybrook Health Sciences Centre
Agency class:
Other
Collaborator:
Agency:
Princess Margaret Hospital, Canada
Agency class:
Other
Collaborator:
Agency:
MOUNT SINAI HOSPITAL
Agency class:
Other
Collaborator:
Agency:
Trillium Health Partners
Agency class:
Other
Source:
Sunnybrook Health Sciences Centre
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06247449
