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NCT Number: NCT06268405

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liquid Biopsy

Genetic

Detects cell-free DNA (cfDNA) circulating in the blood by whole-genome sequencing (WGS). It also detects cfDNA containing epigenetic marks by cell-free methylated DNA immunoprecipitation and high throughput sequencing assays and may determine the concordance of genomic alterations between tumour tissue (if available) and matched plasma samples by WGS.

Positron Emission Mammography (PEM)

Device

PEM produces high-sensitivity images of breasts with low levels of F-18 FDG.

Primary outcomes

  1. Evaluating the performance of PEM and Liquid Biopsy in visualizing and characterizing breast abnormalities

    Time frame: 3 years

    The performance of PEM and/or Liquid Biopsy, including percent sensitivity, specificity, positive and negative predictive values, in visualization and characterization of suspicious breast abnormalities will be evaluated and compared to magnetic resonance imaging (MRI), and digital mammography.

Study contacts

Contact information is provided by the study sponsor or research team.

Samira Taeb, MSc

CONTACT

[email protected]

416-946-4501 ext. 5853

Vivianne Freitas, MD

CONTACT

[email protected]

416-946-2000 ext. 5608

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Radialis Inc.
  • The Princess Margaret Cancer Foundation

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Feb 20, 2024
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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