Accuracy Evaluation of Artificial Intelligence Assisted Liver Tumor Ablation Path Planning

NCT05161624 | Unknown

• 1 other identifier: AIasAb
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Receiver operating characteristic curve, ROC

  2 years

Secondary Outcomes (1)

• Area under curve, AUC

  2 years

Study Arms (3)

Path planning model

Diagnostic Test: Accuracy evaluation

Junior ablation specialists

Senior ablation specialists

Interventions

Accuracy evaluation 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.

Path planning model

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Liver tumor patient with goal for non-evidence disease

You may qualify if:

• years old patients with liver tumors, not limited to primary liver cancer or secondary liver metastases;
• The number of tumors is less than 5;
• The diameter of the tumor is less than 3 cm;
• No local treatment of intrahepatic tumors has been done in the past.

You may not qualify if:

• Diffuse liver tumor;
• Multiple lesions in the liver\> 3cm, which cannot be completely ablated;
• Patients with lymph node metastasis and distant metastasis outside the liver;
• Other situations where the researcher believes that it is necessary to withdraw from the study

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 17, 2021
• Study Start: December 15, 2021
• Primary Completion: February 28, 2022
• Study Completion: April 30, 2022
• Last Updated: December 17, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)