The objective of the study is to assess the additional value of monitoring segmental liver function with HBS in patients undergoing SIRT.
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is defined as segmental liver function in
treated and untreated lobes expressed as absolute value (%/min/m2) and
percentage of total liver function 6 weeks after SIRT; and changes in total
liver function after SIRT.
Secondary outcome
Secondary endpoint is the correlation of scintigraphic findings with clinical
and biochemical parameters such as performance score, Chil-Pugh-Turcotte score
and serologic liver function tests collected as part of the routine patient
management.
Background summary
Selective internal radiation therapy (SIRT) is a form of brachytherapy in which
intra-arterially injected (90)Y-loaded microspheres serve as sources for
internal radiation purposes of liver tumors. Average disease control range from
70% up to 90% or even higher and SIRT is usually very well tolerated. Most
complications are mild and can be prevented by careful patient selection.
Severe complications result from the excessive irradiation of non-target liver
tissue. This can lead to radioembolization induced liver disease (REILD), a
potentially life threatening complication. Furthermore, SIRT will result in a
(temporary) decreased liver function due to the irradiation of the non-target
liver tissue.
It could be beneficial to perform SIRT in two sessions enabling the primary
untreated liver segments to guarantee liver function until function in the
treated segments has recovered. Though, changes in the liver function after
SIRT have not been described before.
Currently, HBS is the only liver function test able to measure both the total
and regional liver function. For liver surgery, HBS has been validated as a
tool to assess liver function and is performed routinely in patients before
major liver resection in the AMC. It is also used to assess segmental liver
function before and after portal vein embolization in patients with
insufficient future remnant liver.
Therefore, we consider HBS a valuable quantitative liver function test enabling
assessment of changes in the liver function after SIRT.
Study objective
The objective of the study is to assess the additional value of monitoring
segmental liver function with HBS in patients undergoing SIRT.
Study design
The study is designed as a prospective, single arm, observational cohort study
in 20 patients.
Study burden and risks
An increase in radiation exposure is involved with the additional HBS-SPECT.
Radiation burden for this procedure is 13.6 mSv for both scans. . The
additional radiation burden is >10mSv which is considered a moderate risk
category for adults. Tough, patients will be also treated with high dose SIRT
because of an unresectable tumor in the liver. Furthermore, the life expectancy
in this patient group is limited and the risk of suffering long term
consequences due to the additional radiation caused by SPECT-CT is small. In
this light the additional amount of radiation exposure can be seen as
justifiable.
Furthermore patients need to fast during minimal 4 hours before the procedure,
though patients who undergo HBS prior to liver resection or because of PVE
experience little discomfort as a consequence of the fasting. Moreover,
patients will be injected with 200 MBq 99mTc-mebrofenin intravenously. Though,
HBS is a safe procedure with no procedure related complication
Furthermore, the burden for subjects consists of two visits to the hospital to
perform two HBS scans.
The blood drawings and all the biochemical parameters that will be measured are
already part of standard SIRT protocol.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Patients with hepatocellular carcinoma or liver metastases of other primary who are referred for SIRT.
Age * 18 years.
Signed informed consent obtained prior to any study-specific procedure.
Exclusion criteria
Age * 18 years.
Pregnancy or breastfeeding.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL44984.018.13 |