RecruitingNot ApplicableNCT06268405

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

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


Sponsor

University Health Network, Toronto

Enrollment

100 participants

Start Date

Sep 21, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria3

  • 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 Criteria4

  • 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

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Interventions

GENETICLiquid Biopsy

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.

DEVICEPositron Emission Mammography (PEM)

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


Locations(1)

University Health Network

Toronto, Ontario, Canada

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NCT06268405


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