Abdominal pressure device to control breathing during stereotactic radiotherapy for peripheral non-small cell lung cancer
A Single Center, Translational Study on the Feasibility and Effectiveness of Respiratory Movement Management in Lung Cancer Patients Receiving Stereotactic Radiotherapy Using a Novel Positional Fixation Device
This project tries an abdominal pressure device to reduce breathing-related tumor movement during stereotactic radiotherapy for people with solitary peripheral non-small cell lung cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT07561567 on ClinicalTrials.gov |
What this trial studies
This observational study will test whether a novel positional abdominal pressure fixation device, together with chest and abdominal compression and breathing management, reduces respiratory-induced tumor motion in patients receiving stereotactic body radiotherapy (SBRT). Participants will use the device during simulation and treatment while clinicians record device usage and measure changes in tumor movement. The protocol collects safety and tolerability data for the compression/positional fixation as well as quantitative measures of respiratory motion before and during treatment. Patients with central or super-central tumors or those unable or unwilling to tolerate compression are excluded.
Who should consider this trial
Good fit: Ideal candidates are people with a solitary peripheral non-small cell lung cancer who are judged suitable for SBRT and who can tolerate and agree to chest and abdominal compression with the positional fixation device.
Not a fit: Patients with central or super-central tumors, multiple lesions, or those intolerant or unwilling to undergo respiratory suppression and chest/abdominal compression are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the device could reduce tumor motion during SBRT, allowing smaller treatment margins and potentially sparing healthy lung tissue from radiation.
How similar studies have performed: Similar approaches such as abdominal compression and respiratory gating have shown variable success in reducing tumor motion, while this specific positional fixation device appears to be a newer or less-studied approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Clinical diagnosis is solitary peripheral lung cancer, and after comprehensive evaluation by the participating physicians based on the patient's clinical data, it is suitable for receiving SBRT treatment; Exclusion Criteria: Central or super central lung cancer patients who are intolerant or unwilling to undergo respiratory suppression and chest and abdominal compression fixation
Where this trial is running
Tianjin
- Tianjin Medical University Cancer Institute and Hospital — Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Xuyao Yu Dr
- Email: yuxuyao@tmu.edu.cn
- Phone: 86-022-23341405
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.