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Breath-Hold radiation study aims to sharpen breast cancer treatment

NCT ID NCT07498855

Knowledge-focused Sponsor: Ruijin Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether a deep inspiration breath-hold (DIBH) technique during radiation therapy for breast cancer keeps the radiation dose on target and protects nearby organs. About 25 women who have had breast cancer surgery will be observed. The goal is to see if the planned radiation coverage stays within safe limits during treatment.

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

About 25 people

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

Started

Oct 2025

Expected to finish

May 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.

Who is studied

Female patients aged ≥18 years with left-sided postoperative invasive breast cancer scheduled for DIBH radiotherapy targeting the internal mammary and regional lymph nodes at Ruijin Hospital, Shanghai JiaoTong University School of Medicine. The study will recruit a total of 25 participants, divided into three cohorts based on different respiratory gating tolerances (3 mm, 2 mm, and 1.5 mm).

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: 1. Provide a signed and dated informed consent form (ICF) before the initiation of any trial-specific procedures. 2. Female patients aged ≥ 18 years. 3. Histologically confirmed invasive breast cancer. 4. Have received breast-conserving surgery or mastectomy with axillary staging, including sentinel lymph node biopsy and/or axillary lymph node dissection. 5. Able to hold breath for more than 30 seconds after deep inspiration. 6. Planned to receive postoperative radiotherapy targeting regional lymph nodes, including the internal mammary nodes, under DIBH conditions. 7. Planned to undergo moderate hypofractionated radiotherapy. 8. Karnofsky Performance Status (KPS) score ≥ 80. 9. The estimated life expectancy of greater than 5 years . 10. Sufficient wound healing from surgery, with no signs of active infection at the intended radiation site. Exclusion Criteria: 1. Pregnant or breastfeeding women. 2. Presence of any severe, uncontrolled comorbidity or medical condition that, in the investigator's judgment, would render the participant unsuitable for the study, compromise protocol compliance, or confound the interpretation of study results. 3. Unable to understand or comply with breath-hold training instructions. 4. Right-sided breast cancer.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma 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

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Contacts and locations

Locations

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 200025, China

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