Evaluating Liquid Biopsy and Positron Emission Mammography for High-risk Breast Cancer Detection
Breast Cancer Combined Visualization And Characterization Tools - Novel Positron Emission Mammography System and Liquid Biopsy
NA · University Health Network, Toronto · NCT06268405
This study is testing two new tests, a blood test and a special imaging scan, to see if they can help women at high risk for breast cancer find it earlier.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Health Network, Toronto (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06268405 on ClinicalTrials.gov |
What this trial studies
This research evaluates the effectiveness of two innovative tests, Liquid Biopsy and Positron Emission Mammography (PEM), in women identified as high-risk for breast cancer. Participants will undergo a blood draw for the Liquid Biopsy and a PEM imaging exam to assess breast abnormalities. The study aims to determine if the results from these tests can enhance the ability of radiologists to visualize and characterize suspicious breast lesions, potentially leading to earlier detection of breast cancer. Following these tests, participants may also have an MRI-guided biopsy if necessary.
Who should consider this trial
Good fit: Ideal candidates are women over 18 years old who are scheduled for an MRI-guided biopsy due to high-risk screening imaging findings.
Not a fit: Patients without suspicious lesions detected by standard mammograms or MRIs will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved early detection of breast cancer in high-risk women.
How similar studies have performed: While the combination of Liquid Biopsy and PEM is a novel approach, similar studies have shown promise in enhancing cancer detection methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals who are older than 18 years of age * Individuals who are planned to undergo an MRI-guided biopsy based on high- risk screening imaging detected lesions * Individuals with the ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * High-risk Individuals with screening-imaging studies without suspicious lesions detected by the standard of care mammogram and/or MRI * Individuals who are pregnant or who think they may be pregnant * Individuals who are breast-feeding * Individuals with known allergies to F-18 FDG
Where this trial is running
Toronto, Ontario
- University Health Network — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Vivianne Freitas, MD — University Health Network, Toronto
- Study coordinator: Samira Taeb, MSc
- Email: samira.taeb2@uhn.ca
- Phone: 416-946-4501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Positron Emission Mammography, Liquid Biopsy