Lung Cancer, Non-Small CellE20241186NCT07561567
Feasibility and Effectiveness of Respiratory Movement Management in Lung Cancer Receiving Stereotactic Radiotherapy Using a Novel Positional Fixation Device
An observational study of Lung Cancer, Non-Small Cell, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
The purpose of this clinical trial is to understand the safety and effectiveness of abdominal pressure devices in inhibiting respiratory movement in lung cancer patients. The main question it aims to answer is: Did the abdominal pressure device reduce the respiratory movement of participants with lung cancer tumors?… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Non-Small Cell
- What is being tested?
- Chest and abdominal compression and breathing management
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2026to 31 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This trial will enroll 50 patients with NSCLC scheduled to receive SBRT
Who may be able to join
- 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;
Who cannot join
- Central or super central lung cancer patients who are intolerant or unwilling to undergo respiratory suppression and chest and abdominal compression fixation
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, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Xu Yao Yu, +862223340123, yuxuyao@tmu.edu.cn
About this study
Official title: 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
The purpose of this clinical trial is to understand the safety and effectiveness of abdominal pressure devices in inhibiting respiratory movement in lung cancer patients. The main question it aims to answer is:
Did the abdominal pressure device reduce the respiratory movement of participants with lung cancer tumors?
Participants will:
Record how much they use abdominal pressure devices to suppress lung cancer tumor respiratory movement
- Conditions
- Lung Cancer, Non-Small Cell
- Being tested
- Chest and abdominal compression, breathing management
- Keywords
- Respiratory Movement Management
- 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.
Chest and abdominal compressionDevice
Abdominal compression suppresses respiratory movement in patients
breathing managementDevice
Apply pressure to the patient's abdomen to achieve respiratory movement inhibition
| Study group | Role | What they receive |
|---|---|---|
| Breathing management group | CT/4DCT scan under breathing management Receives: Device: Chest and abdominal compression; Device: breathing management | |
| No breathing management group | CT/4DCT scan under free breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor displacement range
Based on 4DCT for delineating tumor motion range and extracting radiomics features in patients with and without respiratory management
Measured: Within 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start10 May 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Non-Small CellStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561567
- Sponsor's protocol ID
- TJMUCH358-2023-15
- Acronym
- E20241186
- Status last verified
- Jan 2026
- First submitted
- 24 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07561567
- Acronym / sponsor ID
- E20241186 / TJMUCH358-2023-15
- Conditions
- Lung Cancer, Non-Small Cell
- Keywords
- Respiratory Movement Management
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 10 May 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 May 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.
The purpose of this clinical trial is to understand the safety and effectiveness of abdominal pressure devices in inhibiting respiratory movement in lung cancer patients. The main question it aims to answer is:
Did the abdominal pressure device reduce the respiratory movement of participants with lung cancer tumors?
Participants will:
Record how much they use abdominal pressure devices to suppress lung cancer tumor respiratory movement
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breathing management group | – | Device: Chest and abdominal compression, Device: breathing managementCT/4DCT scan under breathing management |
| No breathing management group | – | –CT/4DCT scan under free breathing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This trial will enroll 50 patients with NSCLC scheduled to receive SBRT
Key inclusion criteria (1 listed)
- 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;
Key exclusion criteria (1 listed)
- Central or super central lung cancer patients who are intolerant or unwilling to undergo respiratory suppression and chest and abdominal compression fixation
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 |
|---|---|---|
| Chest and abdominal compressionAbdominal compression suppresses respiratory movement in patients | Device | Breathing management group |
| breathing managementApply pressure to the patient's abdomen to achieve respiratory movement inhibition | Device | Breathing management group |
Primary outcome
Tumor displacement range
Time frame: Within 6 months after enrollment
Based on 4DCT for delineating tumor motion range and extracting radiomics features in patients with and without respiratory management
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 1 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, Non-Small Cell, 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 1 May 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?
Contact Xuyao Yu Dr (86-022-23341405, yuxuyao@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor displacement range (time frame: Within 6 months after enrollment). 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 1 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.