Streamlining Radioembolization for Small HCC

NCT ID: NCT06979219

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

146 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-10

Study Completion Date

2029-12-31

Brief Summary

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In patients who has no sign suggesting high lung shunt fraction (TIPS, hepatic vein invasion, hepatic vein enhancement on arterial phase, dysmorphic intratumoral vessel, tumor size \< 5cm), radioembolization is performed without MAA scan with SIR-Spheres. This prospective registry will prove that the selection criteria is accurate and streamlining radioembolization is feasible and safe.

Detailed Description

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Conditions

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Hepatocellular Carcinoma (HCC)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Streamlining group

radioembolization is performed without MAA scan

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* HCC can be diagnosed by AASLD guideline
* hepatocellular carcinoma 5cm or smaller
* dysmorphic intratumoral vessels 3mm or smaller
* Child-Pugh class A
* ECOG 0 or 1
* the following lab should be met. A. Leukocytes ≥ 1,000/µL and ≤ 20,000/µL B. Hemoglobin ≥ 6.0 g/dL (transfusion allowed to meet this criterion) C. Total bilirubin ≤ 2.0 mg/dL D. Platelet ≥ 40,000/µL E. International normalized ratio (INR) ≤ 2.0 for patients not taking anticoagulants F. Aspartate transaminase (AST) ≤ 800 IU/L (i.e., ≤ 20X upper normal limit) G. Alanine transaminase (ALT) ≤ 800 IU/L (i.e., ≤ 20X upper normal limit) H. Creatinine ≤ 2.5 mg/dL (if patient is receiving hemodialysis, no upper limit of creatinine)

Exclusion Criteria

* hepatic vein invasion on CT/MRI
* hepatic vein enhancement on arterial phase of CT/MRI
* TIPS
* dysmorphic intratumoral vessels \> 3mm
* main portal vein invasion
* significant COPD or interstitial lung disease
* biliary stent or bilioenteric anastomosis
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyo-Cheol Kim

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Cancer Center

Goyang, , South Korea

Site Status RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status NOT_YET_RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Severance hospital

Seoul, , South Korea

Site Status NOT_YET_RECRUITING

Countries

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South Korea

Central Contacts

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Hyo-Cheol Kim, MD

Role: CONTACT

82-10-5136-5205

Facility Contacts

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In Joon Lee, MD

Role: primary

82-10-6429-2012

Dong Ho Hyun, MD

Role: primary

82-10-8809-6722

Hyo-Cheol Kim, MD

Role: primary

82-10-5136-5205

Gyoung Min Kim

Role: primary

821042430703

Other Identifiers

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2503-052-1620

Identifier Type: -

Identifier Source: org_study_id

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