Positron Emission Mammography and Liquid Biopsy in Women With High-risk Breast Screenings
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Liquid Biopsy, Positron Emission Mammography (PEM).
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Breast Cancer Combined Visualization And Characterization Tools - Novel Positron Emission Mammography System and Liquid Biopsy
Overview
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.
Interventions
- 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 assays 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.
Primary outcome measures
- Evaluating the performance of PEM and Liquid Biopsy in visualizing and characterizing breast abnormalities [Time frame: 3 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Canada · 1 center
- University Health Network — Toronto
Identifiers
NCT: NCT06268405 · 22-5806