Prospective Post Y90 Liver Hypertrophy
Prospective Study of Early Contra-lateral Liver Lobar Hypertrophy After Unilobar Y-90 Selective Internal Radiation Therapy (SIRT) in Patients With Hepatocellular Carcinoma (HCC)
1 other identifier
observational
25
1 country
1
Brief Summary
Patients undergoing Y90 radioembolization to will be followed prospectively with CT volumetry to determine post-Y90 rate of liver hypertrophy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 17, 2016
CompletedFirst Posted
Study publicly available on registry
May 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedFebruary 14, 2017
February 1, 2017
2.5 years
May 17, 2016
February 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
liver hypertrophy
Primary outcomes: The rate of change in volume of the contralateral liver volume from baseline
CT volumetry will be performed at: 1) within 1 month of radioembolization; 2) 4 to 6 weeks and 3) 8 to12 weeks after SIRT.
Study Arms (1)
Post Y90 hypertrophy measurement
All prospective patients who undergo unilobar SIRT for HCC at SGH or NCC are potential candidates for this study. The study aims to recruit 25 subjects and it is anticipated that 50% will be from SGH and 50% will be from NCC
Interventions
Liver volume will be measure at 3 time points. All patients will undergo CT volumetry at baseline, 4-6 weeks and 8-12 weeks after SIRT. The images are then measured using a commercially available 3D software (Vital's Vitrea Advanced CT Liver Oncology package) and manually corrected, reviewed and resected by a single senior radiologist to ensure consistency in following the same anatomical landmarks.
Eligibility Criteria
All prospective patients who undergo unilobar SIRT for HCC at SGH or NCC are potential candidates for this study. The study aims to recruit 25 subjects and it is anticipated that 50% will be from SGH and 50% will be from NCC.
You may qualify if:
- All patients with HCC who are to receive SIRT
- The diagnosis of HCC is made based on current diagnostic criteria i.e. a characteristic appearance on contrast-enhanced quadriphasic CT scan and/or MRI, raised serum AFP levels and the presence of known risk factors
- Patients with tumor confined in the right/left lobe who will receive unilobar SIRT to the right/left hepatic artery
- All adult patients above 21 are eligible for the study
- Able to provide informed consent
You may not qualify if:
- Patients who received SIRT not confined to the left or right lobe
- Patients who received other concomitant treatment
- Patients with bilobar disease at the time of treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Singapore General Hospital
Singapore, Singapore, 169608, Singapore
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Goh, MBBS
Singhealth Foundation
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2016
First Posted
May 26, 2016
Study Start
June 1, 2014
Primary Completion
December 1, 2016
Study Completion
March 1, 2017
Last Updated
February 14, 2017
Record last verified: 2017-02