Prospective Study of Early Contra-lateral Liver Lobar Hypertrophy After Unilobar Y-90 Selective Internal Radiation Therapy (SIRT) in Patients With Hepatocellular Carcinoma (HCC)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Singapore General Hospital
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- liver hypertrophy
Study Overview
Brief Summary
Patients undergoing Y90 radioembolization to will be followed prospectively with CT volumetry to determine post-Y90 rate of liver hypertrophy.
Detailed Description
Study protocol: Prospective study of early contra-lateral liver lobar hypertrophy after unilobar Y-90 selective internal radiation therapy (SIRT) in patients with hepatocellular carcinoma (HCC)
All patients scheduled to undergo unilobar (Right or left) SIRT with Y-90 for HCC at the Singapore General Hospital or the National Cancer Center Singapore during the study period may be enrolled. The target sample size is 25 over 2 years
Information on baseline demographics and disease staging, as well as pre- and post-treatment tumour and liver dimensions would be prospectively obtained.
The diagnosis of HCC is made based on current accepted diagnostic criteria ie. a characteristic appearance on contrast-enhanced quadriphasic CT scan and/or MRI, raised serum AFP levels and the presence of known risk factors. The RECIST criteria will be used to evaluate tumour response and disease progression at the time of the final volume determination.
Patients scheduled for unilobar SIRT will be consented for the study and enrolled into the study.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 21 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Patients must meet all the above inclusion criteria to be enrolled into the study
Exclusion Criteria
- •Any patient with the following exclusion criteria will not be eligible for the study:
- •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
Outcomes
Primary Outcomes
liver hypertrophy
Time Frame: CT volumetry will be performed at: 1) within 1 month of radioembolization; 2) 4 to 6 weeks and 3) 8 to12 weeks after SIRT.
Primary outcomes: The rate of change in volume of the contralateral liver volume from baseline
Secondary Outcomes
No secondary outcomes reported