NCT05627297

Brief 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. 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 25, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

November 25, 2022

Status Verified

November 1, 2022

Enrollment Period

1.9 years

First QC Date

November 16, 2022

Last Update Submit

November 16, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Good/Poor overall survival

    2022/12/01-2025/12/01

Study Arms (2)

SR

Other: CEUS and CEMRI

RFA

Other: CEUS and CEMRI

Interventions

contrast-enhanced ultrasound and contrast-enhanced MRI examination

RFASR

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

200

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Wentao Kong

    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2022

First Posted

November 25, 2022

Study Start

December 1, 2022

Primary Completion

November 1, 2024

Study Completion

November 1, 2025

Last Updated

November 25, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations