An interventional study of Novel Respiratory Immobilization Device for Lung SBRT in Non-Small Cell Carcinoma of Lung, sponsored by Tianjin Medical University Cancer Institute and Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Tianjin Medical University Cancer Institute and Hospital · Not applicable, Interventional, and Treatment
This single-center study evaluates a novel body position and breath-holding device for lung cancer patients receiving stereotactic body radiation therapy. We will enroll 50 patients with single peripheral non-small cell lung cancer, compare tumor movement and radiation dose distribution with and without the device, to test if the device is safe, feasible and can improve treatment accuracy.
For patients with peripheral non-small cell lung cancer receiving stereotactic body radiation therapy, respiratory motion often causes target volume deviation and compromises dose accuracy to tumors and nearby organs at risk. Current standard immobilization methods have limited ability to stabilize deep breathing patterns. This single-center translational study uses an integrated body position and breath-holding device, enrolling 50 eligible patients who will undergo 4DCT scans both with and without the device while keeping their clinical SBRT treatment plan unchanged. We will compare tumor motion amplitude, target coverage, conformity index and organ dose parameters between the two scanning states, to verify the device's feasibility, safety and value in improving treatment precision, providing clinical evidence for wider application in lung SBRT.
6,666 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,682 are open to participants now.
This study's planned enrollment of 50 is below the median of 62 across 5,345 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 493 studies on the registry; 292 are open to participants now.
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Exclusion Criteria:
All enrolled patients receive 4DCT with and without the device
Device: Novel Respiratory Immobilization Device for Lung SBRT
A novel immobilization device used for respiratory motion management during lung stereotactic body radiation therapy
Mean respiratory motion amplitude of GTV and organs at risk (OARs) measured on 4DCT before and after abdominal pressure immobilization
Respiratory motion amplitude (maximum displacement) of gross tumor volume (GTV) and organs at risk (OARs) will be contoured and extracted from pre-abdominal-pressure 4DCT and post-abdominal-pressure 4DCT. The difference in motion amplitude between the two states will be compared to evaluate the feasibility and effectiveness of the novel abdominal pressure positioning membrane for lung SBRT.
Time frame: through study completion, an average of 1 year
Conformity index (CI) of SBRT planning target volume (PTV)
CI of PTV calculated from SBRT dose distribution after abdominal pressure immobilization
Time frame: At the time of SBRT plan design, prior to treatment delivery
Coverage of planning target volume (PTV)
PTV coverage calculated from SBRT dose distribution after abdominal pressure immobilization
Time frame: At the time of SBRT plan design, prior to treatment delivery
Maximum relative dose at 2 cm outside the PTV boundary (D2cm)
Percentage of maximum dose at the region 2 cm outside PTV boundary on SBRT plan
Time frame: At the time of SBRT plan design, prior to treatment delivery
Volume of normal ipsilateral lung receiving ≥20Gy,15Gy,10Gy and 5Gy (V20，V15, V10, V5)
Dose-volume histogram parameters of normal treated lung from abdominal-pressure SBRT plan
Time frame: At the time of SBRT plan design, prior to treatment delivery
Maximum dose (Dmax) to organs at risk including spinal cord, heart and esophagus
Dmax of OARs derived from SBRT dose plan under abdominal pressure immobilization
Time frame: At the time of SBRT plan design, prior to treatment delivery
Plan to share: No — This is an exploratory feasibility study, and no public sharing of individual patient data is planned.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Carcinoma, Non-Small-Cell Lung →
Tianjin Medical University Cancer Institute and Hospital →