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

Last updated: September 25, 2024
Sponsor: University Health Network, Toronto
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

Liquid Biopsy

Positron Emission Mammography (PEM)

Clinical Study ID

NCT06268405
22-5806
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Individuals who are older than 18 years of age

  • Individuals who are planned to undergo an MRI-guided biopsy based on high- riskscreening imaging detected lesions

  • Individuals with the ability to understand and the willingness to sign a writteninformed consent document

Exclusion

Exclusion Criteria:

  • High-risk Individuals with screening-imaging studies without suspicious lesionsdetected 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

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Liquid Biopsy
Phase:
Study Start date:
September 21, 2023
Estimated Completion Date:
September 21, 2026

Connect with a study center

  • University Health Network

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

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