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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-21

Study Completion Date

2026-09-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Liquid Biopsy

Intervention Type GENETIC

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 assays and may determine the concordance of genomic alterations between tumour tissue (if available) and matched plasma samples by WGS.

Positron Emission Mammography (PEM)

Intervention Type DEVICE

PEM produces high-sensitivity images of breasts with low levels of F-18 FDG.

Interventions

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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 assays and may determine the concordance of genomic alterations between tumour tissue (if available) and matched plasma samples by WGS.

Intervention Type GENETIC

Positron Emission Mammography (PEM)

PEM produces high-sensitivity images of breasts with low levels of F-18 FDG.

Intervention Type DEVICE

Eligibility Criteria

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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
* Individuals with known allergies to F-18 FDG

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No