Liver TumorNCT05161624
Accuracy Evaluation of Artificial Intelligence Assisted Liver Tumor Ablation Path Planning
An observational study of Liver Tumor, run by Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Tumor
- What is being tested?
- Accuracy evaluation
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2021to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: Liver tumor patient with goal for non-evidence disease
Who may be able to join
- 18-70 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Accuracy evaluation
- Keywords
- liver tumor, ablation, path planning, artificial intelligence, accuracy evaluation
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accuracy evaluationDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Path planning model | Not described Receives: Diagnostic Test: Accuracy evaluation | |
| Junior ablation specialists | Not described | |
| Senior ablation specialists | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receiver operating characteristic curve, ROC
Measured: 2 years
Secondary outcomes (1)
Area under curve, AUC
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start15 Dec 2021 (estimated)
- Primary completion28 Feb 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TumorStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang Jinhua, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161624
- Sponsor's protocol ID
- AIasAb
- Status last verified
- Dec 2021
- First submitted
- 3 Dec 2021
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy Evaluation of Artificial Intelligence Assisted Liver Tumor Ablation Path Planning
- ClinicalTrials.gov ID
- NCT05161624
- Acronym / sponsor ID
- AIasAb
- Conditions
- Liver Tumor
- Keywords
- liver tumor, ablation, path planning, artificial intelligence, accuracy evaluation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Dec 2021 (estimated)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Path planning model | – | Diagnostic Test: Accuracy evaluation |
| Junior ablation specialists | – | – |
| Senior ablation specialists | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Liver tumor patient with goal for non-evidence disease
Key inclusion criteria (4 listed)
- 18-70 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accuracy evaluationThe 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. | Diagnostic test | Path planning model |
Primary outcome
Receiver operating characteristic curve, ROC
Time frame: 2 years
1 secondary outcome
Area under curve, AUC
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Tumor, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Receiver operating characteristic curve, ROC (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021; AzTrials last refreshed its copy on 6 Nov 2026.