Feasibility and Effectiveness of Respiratory Movement Management in Lung Cancer Receiving Stereotactic Radiotherapy Using a Novel Positional Fixation Device (E20241186)
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Xuyao Yu Dr
- Phone Number: 86-022-23341405
- Email: yuxuyao@tmu.edu.cn
Study Locations
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-
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Tianjin, China
- Recruiting
- Tianjin Medical University Cancer Institute and Hospital
-
Contact:
- Xu Yao Yu
- Phone Number: +862223340123
- Email: yuxuyao@tmu.edu.cn
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Breathing management group
CT/4DCT scan under breathing management
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Abdominal compression suppresses respiratory movement in patients
Apply pressure to the patient's abdomen to achieve respiratory movement inhibition
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No breathing management group
CT/4DCT scan under free breathing
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Within 6 months after enrollment
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TJMUCH358-2023-15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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