NCT07498855 Robustness Evaluation of Deep Inspiration Breath-Hold (DIBH) Plans in Internal Mammary Irradiation
| NCT ID | NCT07498855 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ruijin Hospital |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 25 participants in total. It began in 2025-10-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07498855 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07498855 currently recruiting?
Yes, NCT07498855 is actively recruiting participants. Contact the research team at cl11879@rjh.com.cn for enrollment information.
Where is the NCT07498855 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07498855 clinical trial?
NCT07498855 is sponsored by Ruijin Hospital. The trial plans to enroll 25 participants.
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