Non-Small Cell Carcinoma of LungNCT07916129
Single-center Transformational Study on Feasibility and Efficacy of Respiratory Motion Management Using Novel Position Fixation Device for Lung Cancer Patients Undergoing Stereotactic Body Radiation Therapy(2023 No.358 Project)
A study testing Novel Respiratory Immobilization Device for Lung SBRT in people with Non-Small Cell Carcinoma of Lung, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Non-Small Cell Carcinoma of Lung
- What is being tested?
- Novel Respiratory Immobilization Device for Lung SBRT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2025to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate and sign written informed consent
- Age ≥18 years, gender unlimited
- Clinically diagnosed with single peripheral lung cancer, assessed as suitable for SBRT
- Males or females of childbearing age willing to take contraceptive measures during the trial
- Female of childbearing age must have a negative pregnancy test within 7 days before treatment, and all patients use adequate contraception during treatment and for 4 weeks after
Who cannot join
- Intolerant or unwilling to receive the integrated respiratory suppression and positioning immobilization device for radiotherapy localization.
- Currently participating or planning to participate in other clinical trials.
- Refuse or be unable to sign the informed consent form for this trial.
- Patients with central or ultra-central lung cancer.
- Patients planned to receive SBRT for multiple pulmonary lesions.
- Patients assessed by the investigators of this trial as unsuitable for SBRT treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300000
About this study
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.
Read the detailed description
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.
- Conditions
- Non-Small Cell Carcinoma of Lung
- Being tested
- Novel Respiratory Immobilization Device for Lung SBRT
- Keywords
- lung cancer immobilization, respiratory motion management, stereotactic body radiation therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Respiratory Immobilization Device for Lung SBRTDevice
A novel immobilization device used for respiratory motion management during lung stereotactic body radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Single Arm - Novel Respiratory Immobilization | Experimental | All enrolled patients receive 4DCT with and without the device Receives: Device: Novel Respiratory Immobilization Device for Lung SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Conformity index (CI) of SBRT planning target volume (PTV)
CI of PTV calculated from SBRT dose distribution after abdominal pressure immobilization
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At the time of SBRT plan design, prior to treatment delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start10 Sep 2025
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Carcinoma of LungStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group, self-controlled study comparing 4DCT with and without the novel immobilization device
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongchun Song, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916129
- Sponsor's protocol ID
- bc20261997
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is an exploratory feasibility study, and no public sharing of individual patient data is planned.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Transformational Study on Feasibility and Efficacy of Respiratory Motion Management Using Novel Position Fixation Device for Lung Cancer Patients Undergoing Stereotactic Body Radiation Therapy(2023 No.358 Project)
- ClinicalTrials.gov ID
- NCT07916129
- Acronym / sponsor ID
- bc20261997
- Conditions
- Non-Small Cell Carcinoma of Lung
- Keywords
- lung cancer immobilization, respiratory motion management, stereotactic body radiation therapy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group, self-controlled study comparing 4DCT with and without the novel immobilization device
| Arm | Type | Receives |
|---|---|---|
| Single Arm - Novel Respiratory Immobilization | Experimental | Device: Novel Respiratory Immobilization Device for Lung SBRTAll enrolled patients receive 4DCT with and without the device |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Voluntarily participate and sign written informed consent
- Age ≥18 years, gender unlimited
- Clinically diagnosed with single peripheral lung cancer, assessed as suitable for SBRT
- Males or females of childbearing age willing to take contraceptive measures during the trial
- Female of childbearing age must have a negative pregnancy test within 7 days before treatment, and all patients use adequate contraception during treatment and for 4 weeks after
Key exclusion criteria (6 listed)
- Intolerant or unwilling to receive the integrated respiratory suppression and positioning immobilization device for radiotherapy localization.
- Currently participating or planning to participate in other clinical trials.
- Refuse or be unable to sign the informed consent form for this trial.
- Patients with central or ultra-central lung cancer.
- Patients planned to receive SBRT for multiple pulmonary lesions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel Respiratory Immobilization Device for Lung SBRTA novel immobilization device used for respiratory motion management during lung stereotactic body radiation therapy | Device | Single Arm - Novel Respiratory Immobilization |
Primary outcome
Mean respiratory motion amplitude of GTV and organs at risk (OARs) measured on 4DCT before and after abdominal pressure immobilization
Time frame: through study completion, an average of 1 year
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.
5 secondary outcomes
Conformity index (CI) of SBRT planning target volume (PTV)
Time frame: At the time of SBRT plan design, prior to treatment delivery
Coverage of planning target volume (PTV)
Time frame: At the time of SBRT plan design, prior to treatment delivery
Maximum relative dose at 2 cm outside the PTV boundary (D2cm)
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)
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
Time frame: At the time of SBRT plan design, prior to treatment delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No. This is an exploratory feasibility study, and no public sharing of individual patient data is planned.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel Respiratory Immobilization Device for Lung SBRT in people with Non-Small Cell Carcinoma of Lung, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean respiratory motion amplitude of GTV and organs at risk (OARs) measured on 4DCT before and after abdominal pressure immobilization (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.