Recruiting

Positron Emission Mammography & Liquid Biopsy

Sponsor:

University Health Network, Toronto

Code:

NCT06268405

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Liquid Biopsy

Positron Emission Mammography (PEM)

Study Details

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.

Conditions

Breast Cancer

Study ID

NCT06268405

Start date

Sep 21, 2023

Status verified date

Apr, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Positron Emission Mammography (PEM)

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

Primary outcome measure

  • Evaluating the performance of PEM and Liquid Biopsy in visualizing and characterizing breast abnormalities [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Samira Taeb, MSc

416-946-4501samira.taeb2@uhn.ca

Vivianne Freitas, MD

416-946-2000vivianne.freitas@uhn.ca

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Samira Taeb, MSc

416-946-4501samira.taeb2@uhn.ca

Vivianne Freitas

416-946-2000vivianne.freitas@uhn.ca

Principal Investigator:

Vivianne Freitas, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Keywords

  • Positron Emission Mammography (PEM)
  • Liquid Biopsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-04-29.