- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05627297
Applying Artificial Intelligence to Optimize Early-stage Hepatocellular Carcinoma Treatment Based on Multi-modal Image (AI-HCC)
November 16, 2022 updated by: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Artificial Intelligence to Optimize Early-stage Hepatocellular CarcinomaTreatment Based on Multi-modal Image
This study intends to establish two prognostic models based on contrast-enhanced ultrasound (CEUS) and dynamic enhanced magnetic resonance (DE-MRI) multimodal images: prognostic model of liver cancer patients after hepatectomy and prognostic model of liver cancer patients after radiofrequency ablation.
Combined with artificial intelligence imaging omics, traditional imaging omics and clinical information, to predict and compare the prognosis of two different treatment methods for early liver cancer, so as to realize the individual selection of treatment methods for early liver cancer patients
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Wentao Kong
- Phone Number: 13815897824
- Email: breezewen@163.com
Study Contact Backup
- Name: Han Liu
- Phone Number: 13058328870
- Email: liuhanDEonly@163.com
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210009
- Recruiting
- Nanjing Drum Tower Hospital
-
Contact:
- Wentao Kong, Dr
- Phone Number: 13815897824
- Email: breezewem@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
200
Description
Inclusion Criteria:
Primary single hepatocellular carcinoma confirmed by histology or cytology, with a maximum diameter ≤5.0 cm;
Good liver function, Child-Pugh grade A;
- No serious dysfunction of heart, lung, kidney and other important organs ④ Liver resection or radiofrequency ablation was performed in our hospital, and the study protocol and follow-up procedure were followed.
Exclusion Criteria:
Patients who cannot perform DCE-MRI examination due to metal implants in the body ② Patients who had received other treatment before DCE-MRI or CEUS;
- Invisible lesions, diffuse lesions or poor DCE-MRI/CEUS image quality under CEUS; ④ Drug abuse, clinical or psychological or social factors that make informed consent or study implementation affected.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
SR
|
contrast-enhanced ultrasound and contrast-enhanced MRI examination
|
|
RFA
|
contrast-enhanced ultrasound and contrast-enhanced MRI examination
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Good/Poor overall survival
Time Frame: 2022/12/01-2025/12/01
|
2022/12/01-2025/12/01
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Wentao Kong, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 1, 2022
Primary Completion (Anticipated)
November 1, 2024
Study Completion (Anticipated)
November 1, 2025
Study Registration Dates
First Submitted
November 16, 2022
First Submitted That Met QC Criteria
November 16, 2022
First Posted (Actual)
November 25, 2022
Study Record Updates
Last Update Posted (Actual)
November 25, 2022
Last Update Submitted That Met QC Criteria
November 16, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WentaoKong
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.