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The application of 4D-MRI combined with abdominal compression technique in SBRT for liver tumors,a randomized controlled study

The application of 4D-MRI combined with abdominal compression technique in SBRT for liver tumors,a randomized controlled study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075155
Enrollment
Unknown
Registered
2023-08-28
Start date
2023-08-28
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

liver tumors

Interventions

study group,group A:Abdominal compression and vacuum pad were used for body immobilization, followed by simulating CT scanning and 4D-MRI scanning. No intervention is implemented for other radiothera
control group,group B:Conventional abdominal thermoplastic was used for immobilization (without abdominal compression), followed by simulating CT scans and 4D-MRI scans. The method of collecting image

Sponsors

Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Age = 18; 2) ECOG 0-1; 3) Malignant tumors suitable for liver SBRT treatment, including primary hepatocellular carcinoma or liver metastasis; 4) The number of liver tumors = 5, and the diameter of a single tumor = 5cm; 5) Liver function is well reserved (Child-Pugh =B7)and sufficient normal liver tissue (= 700ml). 6) The research subjects fully understand the implementation of the study and voluntarily sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Poor liver function. i.e. Child-Pugh score is greater than 7 points; Or patients with ALT and AST = 2.5 times of the ULN, total bilirubin = 2 times the ULN, ALB = 29g/L; 2) Patients with tumors that are close to the intestines and other organs at risk, such as the stomach, esophagus, duodenum, and jejunum, and are difficult to tolerate SBRT radiation therapy; 3) Patients with residual liver volume<700ml and difficulty tolerating radiotherapy; 4) Individuals who are allergic to iodine contrast agents or gadolinium contrast agents; 5) Individuals with metal in their bodies or with claustrophobia who are unable to complete MRI scans; 6) Those who cannot understand the process of abdominal compression and cannot cooperate to complete the fixation of abdominal compression positions; 7) Pregnant women or patients who still have fertility requirements.

Design outcomes

Primary

MeasureTime frame
cranial-caudal motion amplitude of liver;

Secondary

MeasureTime frame
anterior-posterior motion amplitude of liver;lateral motion amplitude of liver;Liver translocation between CBCT and simulating CT in cranial-caudal, anterior-posterior, lateral direction;tumor volume in simulating CT and MRI;objective response rate;local failure free survival;overall survival;

Countries

China

Contacts

Public ContactHongzhi Wang

Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute

wanghongzhi1988@126.com+86 10 8819 6292

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026