Hepatocellular CarcinomaAI-HCCNCT05627297
Applying Artificial Intelligence to Optimize Early-stage Hepatocellular Carcinoma Treatment Based on Multi-modal Image
An observational study of Hepatocellular Carcinoma, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- CEUS and CEMRI
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 1 Nov 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 200
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210009
Wentao Kong, Dr, 13815897824, breezewem@163.com
About this study
Official title: 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
- Conditions
- Hepatocellular Carcinoma
- Being tested
- CEUS and CEMRI
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEUS and CEMRIOther
contrast-enhanced ultrasound and contrast-enhanced MRI examination
| Study group | Role | What they receive |
|---|---|---|
| SR | Not described Receives: Other: CEUS and CEMRI | |
| RFA | Not described Receives: Other: CEUS and CEMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Good/Poor overall survival
Measured: 2022/12/01-2025/12/01
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wentao Kong, Study chair, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627297
- Sponsor's protocol ID
- WentaoKong
- Acronym
- AI-HCC
- Status last verified
- Nov 2022
- First submitted
- 16 Nov 2022
- Last updated
- 25 Nov 2022
- Results posted
- 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 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence to Optimize Early-stage Hepatocellular CarcinomaTreatment Based on Multi-modal Image
- ClinicalTrials.gov ID
- NCT05627297
- Acronym / sponsor ID
- AI-HCC / WentaoKong
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 25 Nov 2022 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SR | – | Other: CEUS and CEMRI |
| RFA | – | Other: CEUS and CEMRI |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 200
Key inclusion criteria (3 listed)
- Primary single hepatocellular carcinoma confirmed by histology or cytology, with a maximum diameter ≤5.0 cm;
Key exclusion criteria (2 listed)
- 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;
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 |
|---|---|---|
| CEUS and CEMRIcontrast-enhanced ultrasound and contrast-enhanced MRI examination | Other | RFA, SR |
Primary outcome
Good/Poor overall survival
Time frame: 2022/12/01-2025/12/01
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2022.
- 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.
Wentao Kong study chair
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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 Hepatocellular Carcinoma, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 3 inclusion and 2 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 25 Nov 2022. 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?
Contact Wentao Kong (13815897824, breezewen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Good/Poor overall survival (time frame: 2022/12/01-2025/12/01). 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 25 Nov 2022.