Deep inspiration breath-hold planning for internal mammary radiation after breast cancer surgery
Robustness Evaluation of Deep Inspiration Breath-Hold (DIBH) Radiotherapy Plans for Internal Mammary Irradiation in Postoperative Breast Cancer
This test will see if different deep inspiration breath-hold settings (1.5–3 mm gating windows) keep the radiation target covered while protecting the heart and lungs for adults getting postoperative radiotherapy that includes the internal mammary nodes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07498855 on ClinicalTrials.gov |
What this trial studies
This single-center, prospective observational project follows postoperative breast cancer patients planned for regional nodal radiotherapy including the internal mammary nodes under DIBH. Participants are treated with contemporary techniques (IMRT/VMAT and potentially proton therapy) while using surface guidance and imaging to monitor breath-hold and positional variation. The study compares robustness of plans using 1.5 mm, 2 mm, and 3 mm gating windows and quantifies intrafractional and interfractional positional errors. Primary analyses focus on actual target dose coverage and organ-at-risk dose parameters (heart, lung) to determine whether they remain within clinically acceptable ranges during treatment delivery.
Who should consider this trial
Good fit: Adult women who have had breast-conserving surgery or mastectomy with axillary staging, are planned for postoperative regional nodal radiotherapy including the internal mammary nodes under DIBH, can hold a deep breath for >30 seconds, and have good performance status (KPS ≥ 80).
Not a fit: Patients who cannot perform or sustain consistent deep inspiration breath-holds (for example due to respiratory disease, inability to cooperate, or severe fatigue), pregnant or breastfeeding women, or those with uncontrolled comorbidities are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could help keep radiation focused on lymph nodes while lowering heart and lung exposure, potentially reducing long-term cardiac and pulmonary side effects.
How similar studies have performed: DIBH has been shown to reduce cardiac dose in left-sided whole-breast irradiation, but its specific robustness and dosimetric behavior for internal mammary and regional nodal irradiation with advanced IMRT/VMAT/proton techniques remain less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Shanghai Municipality
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Lu Cao, PhD
- Email: cl11879@rjh.com.cn
- Phone: +86-021-64370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.