MedTrace Logo

Robustness Evaluation of Deep Inspiration Breath-Hold (DIBH) Plans in Internal Mammary Irradiation

NCT07498855 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2026-03-27

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-12-31
Completion
2027-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07498855 on ClinicalTrials.gov