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Single-Dose radiation during breast surgery: a new hope?

NCT ID NCT03121469

Symptom relief Sponsor: Centre Antoine Lacassagne 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Updated 1 time

Summary

This study tested a device called Papillon +TM that delivers a single dose of radiation directly to the tumor site during breast cancer surgery. 28 women aged 60 and older with early-stage breast cancer took part. The main goal was to see if the technique was feasible and safe, not to measure long-term cancer control.

What this could mean

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

Active substance
Papillon +TM radiotherapy device
What this could lead to
If successful, this could offer a more convenient way to deliver radiation during breast cancer surgery, potentially reducing the need for follow-up visits.
What could go wrong
This is a very small, early-phase study (28 people) focused on whether the technique is even possible. It is not designed to prove it works better than standard treatment, and long-term safety or effectiveness is unknown.

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

28 people

The number who actually took part.

Started

Oct 2018

Finished

Jun 2025

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

60 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: * Patient with grade 1 or 2 invasive ductal adenocarcinoma or ductal carcinoma in situ, regardless of grade (found on mammography by an outbreak of Single microcalcification with a diameter not exceeding 2 cm or a tumor opacity \<2 cm), * Patient aged 60 years or older (patients 60 years of age in the year may be included); * Unilateral adenocarcinoma, unifocal, positive HR, non-overexpressed HER-2 - T1 N0 radio-clinical , Operable patient with breast volume compatible with conservative surgery, * Patients who have been made aware of the information sheet and have given their written signed informed consent. * Patients benefitting from social health insurance coverage. Exclusion Criteria: * Age less than 60 years * Patient with grade 3 invasive breast carcinoma * Patient with lymphatic invasion / peri-nerve involvement / vascular emboli * Metastatic patient * Multifocal and / or bilateral tumor * N1 proved by ultrasound guided * Patient with psychological and / or psychiatric disorders * Vulnerable patient: a person deprived of liberty by an administrative or judicial decision, a major person who is the object of a legal protection measure or is unable to express his / her consent

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Conditions

The condition(s) this trial relates to.

breast cancer

As listed by the trial registrant

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

Localized breast cancer

Contacts and locations

Locations

  • Centre Antoine Lacassagne

    Nice, 06189, France

More trials for these conditions

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