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New blood test and camera could spot breast cancer earlier, reduce unnecessary biopsies

NCT ID NCT06268405

Diagnosis Sponsor: University Health Network, Toronto Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing two new ways to find breast cancer in women at high risk: a blood test that looks for tumor DNA and a special mammogram that uses a low-dose radioactive tracer. About 100 women who already need a biopsy will get both tests first. The goal is to see if these tools can help doctors see and understand breast abnormalities better than current methods, which could lead to fewer unnecessary biopsies and less worry.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Liquid Biopsy (blood test for tumor DNA) and Positron Emission Mammography (PEM) imaging device
What this could lead to
If successful, these tests could help radiologists spot breast cancer more accurately, potentially reducing unnecessary biopsies and anxiety for high-risk women.
What could go wrong
This is an early-stage study with only 100 participants, so results may not apply to all women. The tests are experimental and may not be more accurate than current methods.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Health Network

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

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