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Single-Dose radiation during lumpectomy: a new option for early breast cancer?

NCT ID NCT04595435

Knowledge-focused Sponsor: Wake Forest University Health Sciences 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 24, 2026 · Updated 3 times

Summary

This registry follows 94 women aged 50 and older with early-stage, low-risk breast cancer who received a single dose of radiation directly to the tumor site during lumpectomy (IORT). The goal is to monitor cancer recurrence, side effects, and patient satisfaction over time. Because IORT is newer and still debated, this study will help clarify its real-world outcomes.

What this could mean

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

Active substance
Intraoperative radiation therapy (IORT) using low-energy X-rays
What this could lead to
If successful, this registry could confirm that IORT is a safe and effective alternative to whole-breast radiation for certain early-stage breast cancers, potentially reducing treatment time and side effects.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove IORT is better than standard radiation. Recurrence rates remain a concern, and results may not apply to all patients.

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.

Participants

94 people

The number who actually took part.

Started

Mar 2019

Expected to finish

Dec 2033

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.

Who is studied

Patients treated at Navicent Health who meet eligibility criteria for IORT-Breast or who have received IORT-Breast within the previous 6 months

Ages

55 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: * Signed informed consent and HIPAA authorization * T1 tumor (less than or equal to 20mm in greatest diameter) * Unifocal * Histological Grade 1 or 2 * Node Negative * ER +ve * HER-2 -ve Exclusion Criteria: * Previous radiation therapy to the involved breast other than IORT within 6 months * High grade tumors (Histologic grade 3) * Her-2 Positive * Lymphovascular invasion * Metastatic disease * close proximity to or involvement of skin * Multifocal cancer

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm female breast carcinoma invasive breast carcinoma

As listed by the trial registrant

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

Breast cancer female Early-stage breast cancer

Contacts and locations

Locations

  • Medical Center, Navicent Health

    Macon, Georgia, 31201, United States

More trials for these conditions

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