Robustness Evaluation of Deep Inspiration Breath-Hold (DIBH) Plans in Internal Mammary Irradiation

Recruiting now

Conditions studied: Breast Cancer

In brief

This study is an investigator-initiated, single-arm, single-center, prospective, observational study. The hypothesis is that during the implementation of deep inspiration breath-hold (DIBH) radiotherapy plans in postoperative breast cancer patients receiving internal mammary irradiation, the actual target dose coverage and organ-at-risk (OARs) dose parameters remain within clinically acceptable ranges.

Key facts

Study ID

NCT07498855

Run by

Ruijin Hospital

People needed

25

Starts

2025-10-01

Expected to finish

2027-05-31

Last updated by the study team

2026-03-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Provide a signed and dated informed consent form (ICF) before the initiation of any trial-specific procedures.
• Female patients aged ≥ 18 years.
• Histologically confirmed invasive breast cancer.
• Have received breast-conserving surgery or mastectomy with axillary staging, including sentinel lymph node biopsy and/or axillary lymph node dissection.
• Able to hold breath for more than 30 seconds after deep inspiration.
• Planned to receive postoperative radiotherapy targeting regional lymph nodes, including the internal mammary nodes, under DIBH conditions.
• Planned to undergo moderate hypofractionated radiotherapy.
• Karnofsky Performance Status (KPS) score ≥ 80.
• The estimated life expectancy of greater than 5 years .
• Sufficient wound healing from surgery, with no signs of active infection at the intended radiation site.

You may not qualify if…

• Pregnant or breastfeeding women.
• 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.
• Unable to understand or comply with breath-hold training instructions.
• Right-sided breast cancer.

Where it is running

• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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