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New scanner aims to cut repeat breast cancer surgeries

NCT ID NCT04999917

Knowledge-focused Sponsor: XEOS Medical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether a high-resolution PET-CT scan of the removed tumor during breast-conserving surgery can help surgeons see if any cancer cells remain at the edges. About 206 women with early-stage breast cancer received a low-dose radioactive tracer before surgery. After the tumor was removed, it was scanned in the operating room, and if the scan suggested cancer at the margin, the surgeon removed extra tissue. The goal was to reduce the 20-30% rate of repeat surgeries needed when margins are not clear.

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

206 people

The number who actually took part.

Started

Jun 2022

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * females with an age over 18 years; * confirmed breast cancer (IDC, DCIS, ILC) with indication to undergo BCS; * a minimal tumor size of 1.0 cm (in at least one dimension): * IDC group: assessed preoperatively on ultrasound; * DCIS subgroup: assessed preoperatively on mammogram; * ILC subgroup: assessed preoperatively on ultrasound; * NAT subgroup: assessed after NAT and before surgery on ultrasound; * patients with IDC who have received NAT (i.e. chemotherapy, immunotherapy or endocrine therapy until eight weeks before BCS) may participate in the study; * vacuum-assisted core breast biopsy is allowed in the DCIS subgroup only; * able to understand treatment protocol and informed consent form; * estimated by the investigator to be compliant for study participation. Exclusion Criteria: * general or local contra-indication for BCS; * previous breast surgery; * inflammatory breast cancer; * radiotherapy of the ipsilateral breast; * vacuum-assisted core breast biopsy for all patients allocated to the IDC, ILC or NAT subgroup (vacuum-assisted core breast biopsy is allowed in the DCIS subgroup as long as the residual tumor size on mammogram is at least 1.0 cm); * patients with DCIS only or ILC, and that have received NAT; * blood glucose level over 200 mg/dL on the day of surgery; * pregnancy or lactation; * participation in other clinical studies with a radiation exposure of more than 1 mSv in the past year; * active bacterial, viral or fungal infection.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma in situ breast neoplasm invasive breast carcinoma

As listed by the trial registrant

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

Breast cancer Breast cancer in situ Breast cancer invasive

Contacts and locations

Locations

  • Gynecology department

    Ghent, Flanders, 9000, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.