Accuracy Evaluation of Artificial Intelligence Assisted Liver Tumor Ablation Path Planning

Liver Tumor Clinical Trial

Official title:

Accuracy Evaluation of Artificial Intelligence Assisted Liver Tumor Ablation Path Planning

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05161624
• Other study ID #: AIasAb
• Status: Not yet recruiting
• Start date: December 15, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: December 2021
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: April 30, 2022
• Est. primary completion date: February 28, 2022
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Neoplasms
• Liver Tumor

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Receiver operating characteristic curve, ROC		2 years
Secondary	Area under curve, AUC		2 years