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

Status: Recruiting
Location: See location...
Intervention Type: Device, Genetic
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
University Health Network
RECRUITING
Toronto
Contact Information
Primary
Samira Taeb, MSc
samira.taeb2@uhn.ca
416-946-4501
Backup
Vivianne Freitas, MD
vivianne.freitas@uhn.ca
416-946-2000
Time Frame
Start Date: 2023-09-21
Estimated Completion Date: 2026-09-21
Participants
Target number of participants: 100
Treatments
Experimental: Liquid Biopsy and 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.
Related Therapeutic Areas
Sponsors
Leads: University Health Network, Toronto
Collaborators: Radialis Inc., The Princess Margaret Cancer Foundation

This content was sourced from clinicaltrials.gov

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