Clinical trial Recruiting at 1 site Interventional Ages 18 and up Women only

Evaluating Liquid Biopsy and Positron Emission Mammography for High-risk Breast Cancer Detection

Official title: Breast Cancer Combined Visualization And Characterization Tools - Novel Positron Emission Mammography System and Liquid Biopsy

Run by University Health Network, Toronto · NCT06268405 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment100 (estimated)
SponsorUniversity Health Network, Toronto
Academic / other
Locations1 site (Toronto, Ontario)
StatusRecruiting
StartedSeptember 21, 2023
Main results expectedJuly 31, 2026
Study endsJuly 31, 2027
Registry record updatedApril 29, 2026
Trial IDNCT06268405 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients without suspicious lesions detected by standard mammograms or MRIs will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: While the combination of Liquid Biopsy and PEM is a novel approach, similar studies have shown promise in enhancing cancer detection methods.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.