Robustness Evaluation of Deep Inspiration Breath-Hold (DIBH) Plans in Internal Mammary Irradiation
Recruiting · NCT07498855 · Observational (researchers observe without assigning treatment) · Lead sponsor: Ruijin Hospital
View the official record on ClinicalTrials.gov →Interventions studied
DIBH with 1.5 mm Gating WindowDIBH with 2 mm Gating WindowDIBH with 3mm Gating Window
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
1 location listed.
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine - Shanghai, Shanghai Municipality, China