Recruiting
Robustness Evaluation of Deep Inspiration Breath-Hold (DIBH) Plans in Internal Mammary Irradiation
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.
ClinicalTrials.gov IDNCT07498855
PhaseNot Applicable
Enrollment25
SponsorRuijin Hospital
Age18 Years
SexFEMALE
Conditions studied
Breast Cancer
About this study
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.
Interventions
- Radiation: DIBH with 3mm Gating Window — The patient will receive moderately hypofractionated radiotherapy targeting the ipsilateral breast, supraclavicular and internal mammary nodes, and high-risk axillary region, with a prescribed dose of 40 Gy (RBE) /15Fx. IMRT, VMAT, or proton therapy will be chosen based on the radiation oncologist's judgment and patient preference. Respiratory gating tolerance is set at ±1.5 mm (3 mm total). Three simulated CT scans during DIBH will assess gating window positions: CT1: Breath-hold at the center of the gating window. CT2: Breath-hold at the upper edge, simulating maximum thoracic expansion. CT3: Breath-hold at the lower edge, simulating minimum thoracic expansion. Setup errors (intrafraction and interfraction) and respiratory waveforms monitored via Surface Guided Radiation Therapy（SGRT）systems will be recorded for analysis.
- Radiation: DIBH with 2 mm Gating Window — The patient will receive moderately hypofractionated radiotherapy targeting the ipsilateral breast, supraclavicular and internal mammary nodes, and high-risk axillary region, with a prescribed dose of 40 Gy (RBE) /15Fx. IMRT, VMAT, or proton therapy will be chosen based on the radiation oncologist's judgment and patient preference. Respiratory gating tolerance is set at ±1 mm (2 mm total). Three simulated CT scans during DIBH will assess gating window positions: CT1: Breath-hold at the center of the gating window. CT2: Breath-hold at the upper edge, simulating maximum thoracic expansion. CT3: Breath-hold at the lower edge, simulating minimum thoracic expansion. Setup errors (intrafraction and interfraction) and respiratory waveforms monitored via SGRT systems will be recorded for analysis.
- Radiation: DIBH with 1.5 mm Gating Window — The patient will receive moderately hypofractionated radiotherapy targeting the ipsilateral breast, supraclavicular and internal mammary nodes, and high-risk axillary region, with a prescribed dose of 40 Gy (RBE) /15Fx. IMRT, VMAT, or proton therapy will be chosen based on the radiation oncologist's judgment and patient preference. Respiratory gating tolerance is set at ± 0.75 mm (1.5 mm total). Three simulated CT scans during DIBH will assess gating window positions: CT1: Breath-hold at the center of the gating window. CT2: Breath-hold at the upper edge, simulating maximum thoracic expansion. CT3: Breath-hold at the lower edge, simulating minimum thoracic expansion. Setup errors (intrafraction and interfraction) and respiratory waveforms monitored via SGRT systems will be recorded for analysis.
Primary outcomes
- Target coverage of the Planning treatment volume (PTV) (Upon completion of radiotherapy treatment planning, prior to the first fraction of treatment.)
Eligibility information
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.
Study locations
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai Municipality 200025 China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.