Accuracy Evaluation of Artificial Intelligence Assisted Liver Tumor Ablation Path Planning

NCT ID: NCT05161624

Last Updated: 2021-12-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-15
• Study Completion Date: 2022-04-30

Brief Summary

CT-guided microwave ablation is one of the important treatment methods for primary or metastatic liver tumors. It has the advantages of minimally invasive, safe, and economical. For liver tumors with a diameter of less than 3 cm, it can be comparable to surgical resection. However, different doctors have different levels of experience, leading to a high risk of residues after ablation and even complications. The key is to fail to plan the needle placement reasonably. The past research on path planning was mostly conducted by the engineering team, so that the actual clinical needs were not considered comprehensively, and the sample size of verified cases was small, which limited the application of existing models in the clinical application. In previous study, we used artificial intelligence to segment the upper abdominal organs and construct the constraint function to establish the ablation path planning model, and initially verified the effectiveness of the path planning model in a small number of cases. Now it is planned to expand the number of patients enrolled to evaluate the accuracy of the ablation path planning model that we have established.

Conditions

Liver Tumor

Keywords

liver tumor; ablation; path planning; artificial intelligence; accuracy evaluation

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Path planning model

Accuracy evaluation

Intervention Type: DIAGNOSTIC_TEST

The design of the diagnostic trial will include 160 cases of liver tumors with indications for microwave ablation after a multidisciplinary consultation with clinicians (Multiple Disciplinary Team, MDT), including primary liver cancer and metastatic liver tumors, and the tumor diameter is less than 3 cm. The test subjects consist of three groups: a. path planning model, b. junior ablation specialists, c. senior ablation specialists. The three groups will perform microwave ablation path planning on 160 selected cases of liver tumors. The attending professor of the clinical medical group of the department is responsible for scoring, evaluating whether the design of the plan is reasonable, and then comparing the scoring results by using statistical methods to evaluate the accuracy and effectiveness of the path planning model established in this study.

Junior ablation specialists

No interventions assigned to this group

Senior ablation specialists

No interventions assigned to this group

Interventions

Accuracy evaluation

The design of the diagnostic trial will include 160 cases of liver tumors with indications for microwave ablation after a multidisciplinary consultation with clinicians (Multiple Disciplinary Team, MDT), including primary liver cancer and metastatic liver tumors, and the tumor diameter is less than 3 cm. The test subjects consist of three groups: a. path planning model, b. junior ablation specialists, c. senior ablation specialists. The three groups will perform microwave ablation path planning on 160 selected cases of liver tumors. The attending professor of the clinical medical group of the department is responsible for scoring, evaluating whether the design of the plan is reasonable, and then comparing the scoring results by using statistical methods to evaluate the accuracy and effectiveness of the path planning model established in this study.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. 18-70 years old patients with liver tumors, not limited to primary liver cancer or secondary liver metastases;

2. The number of tumors is less than 5;

3. The diameter of the tumor is less than 3 cm;

4. No local treatment of intrahepatic tumors has been done in the past.

Exclusion Criteria

1. Diffuse liver tumor;

2. Multiple lesions in the liver> 3cm, which cannot be completely ablated;

3. Patients with lymph node metastasis and distant metastasis outside the liver;

4. Other situations where the researcher believes that it is necessary to withdraw from the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Huang Jinhua

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

AIasAb

Identifier Type: -

Identifier Source: org_study_id