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)
NCT07916129, Not applicable, Enrolling by invitation, Tianjin Medical University Cancer Institute and Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| 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 |
| NCT number | NCT07916129 | ClinicalTrials.gov |
| Status | Enrolling by invitation | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 50 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Tianjin Medical University Cancer Institute and Hospital | ClinicalTrials.gov |
| Conditions | Non-Small Cell Carcinoma of Lung | ClinicalTrials.gov |
| Interventions | Novel Respiratory Immobilization Device for Lung SBRT | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Mean respiratory motion amplitude of GTV and organs at risk (OARs) measured on 4DCT before and after abdominal pressure immobilization | 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. | ClinicalTrials.gov |
| Secondary | Conformity index (CI) of SBRT planning target volume (PTV) | At the time of SBRT plan design, prior to treatment delivery | CI of PTV calculated from SBRT dose distribution after abdominal pressure immobilization | ClinicalTrials.gov |
| Secondary | Coverage of planning target volume (PTV) | At the time of SBRT plan design, prior to treatment delivery | PTV coverage calculated from SBRT dose distribution after abdominal pressure immobilization | ClinicalTrials.gov |
| Secondary | Maximum relative dose at 2 cm outside the PTV boundary (D2cm) | At the time of SBRT plan design, prior to treatment delivery | Percentage of maximum dose at the region 2 cm outside PTV boundary on SBRT plan | ClinicalTrials.gov |
| Secondary | Volume of normal ipsilateral lung receiving ≥20Gy,15Gy,10Gy and 5Gy (V20，V15, V10, V5) | At the time of SBRT plan design, prior to treatment delivery | Dose-volume histogram parameters of normal treated lung from abdominal-pressure SBRT plan | ClinicalTrials.gov |
| Secondary | Maximum dose (Dmax) to organs at risk including spinal cord, heart and esophagus | At the time of SBRT plan design, prior to treatment delivery | Dmax of OARs derived from SBRT dose plan under abdominal pressure immobilization | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)