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NCT06268405 | RECRUITING | Breast Cancer

Positron Emission Mammography and Liquid Biopsy in Women With High-risk Breast Screenings
Sponsor:

University Health Network, Toronto

Brief Summary:

The goal of this research study is to evaluate the performance of two experimental tests, namely Liquid Biopsy and Positron Emission Mammography (PEM) in women at high risk of breast cancer. The plan for this study is to assess whether findings from the combination or each individual test can assist radiologists in visualizing and characterizing beast abnormalities. Liquid Biopsy is a blood test that can detect early tumours in patients with malignancies, while PEM is an imaging tool equipped with a high-resolution camera that uses a low dose of injected positron emitting isotope to locate breast tumours. Participation in this study entails a blood draw for Liquid Biopsy test and a PEM imaging exam before undergoing a magnetic resonance imaging (MRI) - guided biopsy for a suspicious breast lesion. If PEM and/or Liquid Biopsy provide accurate information to assist radiologists in visualizing and characterizing breast abnormalities, this method may serve as the first step towards establishing these genomic and new imaging technologies as new diagnostic modalities and ultimately reduce the unnecessary biopsies and anxiety in high-risk populations.

Condition or disease

Breast Cancer

Intervention/treatment

Liquid Biopsy

Positron Emission Mammography (PEM)

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : NONE
Primary Purpose : SCREENING
Official Title : Breast Cancer Combined Visualization And Characterization Tools - Novel Positron Emission Mammography System and Liquid Biopsy
Actual Study Start Date : 2023-09-21
Estimated Primary Completion Date : 2025-09-21
Estimated Study Completion Date : 2026-09-21

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
Positron Emission Mammography and Liquid Biopsy in Women With High-risk Breast Screenings

Location Details

NCT06268405

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Canada, Ontario

University Health Network

Toronto, Ontario, Canada, M5G 2M9