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

Recruiting now · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT06268405

Run by

University Health Network, Toronto

People needed

100

Starts

2023-09-21

Expected to finish

2027-07-31

Last updated by the study team

2026-04-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University Health Network — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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