deltatrials
Recruiting INTERVENTIONAL NCT06268405

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

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

Sponsor: Radialis Inc.

Conditions Breast Cancer
Updated 5 times since 2024 Last updated: Apr 28, 2026 Started: Sep 21, 2023 Primary completion: Jul 31, 2026 Completion: Jul 31, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Breast Cancer, this trial is actively recruiting participants. The trial is conducted by Radialis Inc. and has accumulated 5 data snapshots since 2023. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Mar 2024 – ~Jul 2024 · 4 months · monthly snapshotRecruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~May 2026 · 19 months · monthly snapshotRecruitingMay 4, 2026 – present · 2 months · daily APIRecruiting

Change History

5 versions recorded
  1. May 4, 2026 — Present [daily]

    Recruiting

    Phase: NANone

  2. Oct 2024 — May 2026 [monthly]

    Recruiting NA

  3. Sep 2024 — Oct 2024 [monthly]

    Recruiting NA

  4. Jul 2024 — Sep 2024 [monthly]

    Recruiting NA

  5. Mar 2024 — Jul 2024 [monthly]

    Recruiting NA

    First recorded

Sep 2023

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility 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.

Contact Information

Sponsor contact:
  • Radialis Inc.
  • The Princess Margaret Cancer Foundation
  • University Health Network, Toronto
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations