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

Not Applicable

Recruiting

• Conditions: Breast Cancer
• Interventions: Genetic: Liquid Biopsy; Device: Positron Emission Mammography (PEM)

• Registration Number: NCT06268405
• Lead Sponsor: University Health Network, Toronto

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-21
• Study First Submitted: 2024-02-12
• Study First Submitted QC: 2024-02-12
• Study First Posted: 2024-02-20
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-25
• Last Update Posted: 2024-09-30
• Primary Completion: 2025-09-21
• Study Completion: 2026-09-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Liquid Biopsy and Positron Emission Mammography (PEM)	Liquid Biopsy	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.
Liquid Biopsy and Positron Emission Mammography (PEM)	Positron Emission Mammography (PEM)	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.

Primary Outcome Measures

Name	Time	Method
Evaluating the performance of PEM and Liquid Biopsy in visualizing and characterizing breast abnormalities	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.

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada