Clinical trial · Observational
Robustness Evaluation of Deep Inspiration Breath-Hold (DIBH) Plans in Internal Mammary Irradiation
Robustness Evaluation of Deep Inspiration Breath-Hold (DIBH) Radiotherapy Plans for Internal Mammary Irradiation in Postoperative Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DIBH with 1.5 mm Gating Window | Radiation | — | UNRESOLVED |
| DIBH with 2 mm Gating Window | Radiation | — | UNRESOLVED |
| DIBH with 3mm Gating Window | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Arm1: 3 mm Gating Window Group
- description
- Participants will receive regional nodal and internal mammary irradiation using a hypofractionated regimen and the DIBH technique, with a respiratory gating tolerance of ±1.5 mm (a total of 3 mm).
- interventionNames
- Radiation: DIBH with 3mm Gating Window
- label
- Arm2: 2 mm Gating Window Group
- description
- Participants will receive regional nodal and internal mammary irradiation using a hypofractionated regimen and the DIBH technique, with a respiratory gating tolerance of ±1.0 mm (a total of 2 mm).
- interventionNames
- Radiation: DIBH with 2 mm Gating Window
- label
- Arm3: 1.5 mm Gating Window Group
- description
- Participants will receive regional nodal and internal mammary irradiation using a hypofractionated regimen and the DIBH technique, with a respiratory gating tolerance of ± 0.75 mm (a total of 1.5 mm).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available