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

Breast Cancer Clinical Trial

Official title:

A Pilot Research Study: Breast Cancer Combined Visualization And Characterization Tools - Novel Positron Emission Mammography System and Liquid Biopsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06268405
• Other study ID #: 22-5806
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2023
• Est. completion date: September 21, 2024

Study information

• Verified date: February 2024
• Source: University Health Network, Toronto
• Contact: Samira Taeb, MSc
• Phone: 416-946-4501
• Email: samira.taeb2[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 21, 2024
• Est. primary completion date: September 21, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Genetic:
• Liquid 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 (cfMeDIP) and may determine the concordance of genomic alterations between tumour tissue (if available) and matched plasma samples by WGS.

Device:
• Positron Emission Mammography (PEM)
PEM produces high-sensitivity images of breasts with low levels of F-18 FDG.

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of paired samples between Liquid Biopsy data and Positron Emission Mammography (PEM) images	Once PEM and Liquid Biopsy data are obtained, their correlation in paired samples will be evaluated for any novel findings on tumour fragment size and patterns, mutational signatures, variants, or epigenetic changes identified from the Liquid Biopsy that correlate in paired samples with characteristics of the PEM images.	1 year