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

University Health Network, Toronto

Status: Enrolling

Conditions: Breast Cancer

Treatments: Device: Positron Emission Mammography (PEM); Genetic: Liquid Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT06268405

22-5806

Details and patient eligibility

About

The goal of this pilot research study is to compare 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 evaluate if findings from Liquid Biopsy can be matched to images obtained by PEM.

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 an 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 correlations between paired samples are observed between imaging using PEM and the Liquid Biopsy data, further studies will be conducted to evaluate if these techniques can help refine screening investigations and ultimately reduce the unnecessary biopsies and anxiety in high-risk populations.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Liquid Biopsy and Positron Emission Mammography (PEM)

Experimental group

Description:

To perform the Liquid Biopsy assays, a baseline blood sample will be collected prior to the MRI-guided biopsy, and a follow-up blood and a tissue sample (if available) may be requested post-surgery If malignancy is confirmed by the standard of care histopathology results. To perform the Positron Emission Mammography (PEM), participants will be injected with 74 megabecquerel (MBq) of commercially distributed 2-[fluorine-18]-fluoro-2-deoxy-D-glucose (F-18 FDG). Following a delay of one hour for F-18 FDG uptake, the study participants will undergo a bilateral 4-view combination PEM scan.

Treatment:

Genetic: Liquid Biopsy

Device: Positron Emission Mammography (PEM)