Novel Abdominal Compression Positioning Technique for Respiratory Motion Management in Liver Tumors

NCT07745153 | Completed DMC

• 1 other identifier: NFEC-202511-K15
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Research Background The background of this study centers on stereotactic body radiation therapy (SBRT), an advanced form of radiotherapy that is short in duration, highly effective, and easy for patients to comply with. However, even small breathing movements can reduce its precision. Abdominal compression devices have been proven to reduce respiratory motion and are now widely used in clinical practice. This study aims to determine whether a novel abdominal compression positioning technique can control tumor motion as effectively as current abdominal compression devices, whether it works better than traditional thermoplastic masks, and whether it can offer meaningful benefits to patients undergoing radiotherapy. These questions remain to be explored.
2. 2.Study Objectives The purpose of this study is to investigate how different immobilization devices affect the respiratory motion of liver tumors, in order to better assist with target delineation and the delivery of stereotactic body radiation therapy.

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Keywords

SBRT; liver tumor; abdominal compression

Outcome Measures

Primary Outcomes (2)

• Tumor respiratory motion

  Tumor respiratory motion amplitude

  Within 1 week after completion of radiotherapy

• Liver respiratory motion

  Liver respiratory motion amplitude

  Within 1 week after completion of radiotherapy

Secondary Outcomes (1)

• Local control rates

  Within one year after the completion of radiotherapy

Study Arms (2)

Abdominal compression mask group（Experimental Arm）

Using the novel abdominal compression technique

Thermoplastic body mask group（Control Arm）

Without the novel abdominal compression positioning technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who receive radiotherapy at Nanfang Hospital, Southern Medical University and are diagnosed with primary liver cancer, as well as patients with liver metastases originating from other primary sites.

You may qualify if:

• Voluntarily signed informed consent.
• Age ≥ 18 years.
• Patients who require radiotherapy for liver cancer, as determined by the treating physician.
• Life expectancy \> 3 months.

You may not qualify if:

• Discontinuation of radiotherapy or failure to complete the radiotherapy plan as prescribed.
• Presence of serious complications or comorbidities that may affect safety.

Sponsors & Collaborators

• Southern Medical University, China: lead

Study Sites (1)

Department of Radiation Oncology, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, People's Republic of China

Guangzhou, Guangdong, 510515, China

Location

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2026
• First Posted: August 4, 2026
• Study Start: January 1, 2025
• Primary Completion: July 23, 2026
• Study Completion: July 23, 2026
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)