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

Plain Language Summary

Simplified for easier understanding

This study is testing whether a specialized breast imaging scan called positron emission mammography (PEM) combined with a liquid biopsy (a blood test that looks for tumor DNA) can better identify breast cancer in women with high-risk lesions found on MRI. **You may be eligible if...** - You are over 18 years old - You have been identified as high-risk based on breast screening imaging (mammogram or MRI) and are scheduled for an MRI-guided biopsy - You are able to understand and sign the informed consent **You may NOT be eligible if...** - No suspicious lesions were found on your screening imaging - You are pregnant or think you might be pregnant - You are breastfeeding - You have a known allergy to the radiotracer used in the scan (F-18 FDG) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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