NCT07561567

Brief 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? Participants will: Record how much they use abdominal pressure devices to suppress lung cancer tumor respiratory movement

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

May 10, 2026

Expected
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 1, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

April 24, 2026

Last Update Submit

April 24, 2026

Conditions

Keywords

Respiratory Movement Management

Outcome Measures

Primary Outcomes (1)

  • Tumor displacement range

    Based on 4DCT for delineating tumor motion range and extracting radiomics features in patients with and without respiratory management

    Within 6 months after enrollment

Study Arms (2)

Breathing management group

CT/4DCT scan under breathing management

Device: Chest and abdominal compressionDevice: breathing management

No breathing management group

CT/4DCT scan under free breathing

Interventions

Abdominal compression suppresses respiratory movement in patients

Breathing management group

Apply pressure to the patient's abdomen to achieve respiratory movement inhibition

Breathing management group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This trial will enroll 50 patients with NSCLC scheduled to receive SBRT

You may qualify if:

  • 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;

You may not qualify if:

  • Central or super central lung cancer patients who are intolerant or unwilling to undergo respiratory suppression and chest and abdominal compression fixation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2026

First Posted

May 1, 2026

Study Start (Estimated)

May 10, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 1, 2026

Record last verified: 2026-01

Locations