Non-contrast Abbreviated MRI for Secondary Surveillance of HCC

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05690451
• Collaborator: (none)
• Enrollment: 210
• Locations: 3
• Anticipated Duration (Months): 30.1
• Patients Per Site: 70
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

This prospective multicenter study aimed to compare the diagnostic performance of non-contrast abbreviated MRI in detecting recurrent HCC after curative treatment to that of contrast-enhanced liver CT.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Diagnostic Test: non-contrast abbreviated MRI; Diagnostic Test: Contrast enhanced liver CT

Detailed Description

This study was designed as a prospective single-arm intra-individual comparison multicenter study

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 210 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Role of Non-contrast Abbreviated MRI for Secondary Surveillance of Hepatocellular Carcinoma After Curative Treatment: a Prospective Multicenter Study
• Actual Study Start Date: Dec 28, 2021
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Jun 30, 2024

Outcome Measures

Primary Outcome Measures

1. Sensitivity per tumor [Within 6 months from the study completion]

   Sensitivity for detection of recurrent HCC per tumor

Secondary Outcome Measures

1. Specificity per patient [Within 6 months from the study completion]

   Specificity for detection of recurrent HCC per patient

2. Accuracy per patient [Within 6 months from the study completion]

   Accuracy for detection of recurrent HCC per patient

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 85 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

• Age between 20-year old and 85-year old

• Patients with a history of curative treatment for HCC including surgical resection or local ablation

• No recurrence after curative treatment of HCC for more than two years

• Patient who has the plan to perform contrast-enhanced liver CT for secondary surveillance for HCC (i.e., to detect de novo or recurrent HCC)

Exclusion Criteria:

• Estimated GFR less than 60

• Previous history of severe allergic reaction to the iodinated contrast agent

• Patients with claustrophobia who can't undergo MR examination

• Patients having cochlear implants or cardiac pacemaker

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam	Korea (the Republic Of)	Korea, Republic of	13620
2	Asan Medical Center	Seoul	Korea (the Republic Of)	Korea, Republic of	05505
3	Seoul National University Hospital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Principal Investigator: Dong Ho Lee, M.D., Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dong Ho Lee, Clinical professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT05690451
• Other Study ID Numbers: H-2106-183-1230; KCT0006395
• First Posted: Jan 19, 2023
• Last Update Posted: Jan 19, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dong Ho Lee, Clinical professor, Seoul National University Hospital: Secondary surveillance of hepatocellular carcinoma; Contrast enhanced liver CT; non-contrast abbreviated MRI
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Hepatocellular

Study Results

No Results Posted as of Jan 19, 2023