To assess whether radiofrequency ablation in the liver is associated with hypoxia in the rim of the induced necrosis.
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
- Hepatobiliary therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure: The endpoint of this study is the presence (or
absence) of hypoxia (defined as demonstrable FAZA uptake) in the necrotic rim
induced by RFA.
Secondary outcome
not applicable
Background summary
Surgical resection for colorectal liver metastases is applicable in only 15-30%
of patients. Thermal destruction therapies such as radiofrequency ablation
(RFA) use heat to destroy tumor tissue by inducing coagulative necrosis. This
treatment modality is widely used for treatment of non-resectable colorectal
metastases confined to the liver and may provide tumor clearance and increase
life-expectancy. Nonetheless, recent articles on this topic revealed that local
peri-lesional recurrences from colorectal metastases occur in up to 60% of
cases.
In our preclinical work, we tried to elucidate the role of RFA on residual
micrometastases. Recently, we have demonstrated in two different preclinical
models that RFA accelerates the outgrowth of colorectal liver metastases
located at the rim of the induced necrosis. Strikingly, the location of the
accelerated tumor outgrowth is characterized by areas of hypoxia. These results
show the role of hypoxia in tumor growth acceleration following RFA and may
provide an initial explanation for the high local recurrence rates following
RFA in patients. Until now, no clinical data are available on the role of
hypoxia in local recurrences following RFA in the liver. With the research
proposed, we will assess whether radiofrequency ablation in the liver is
associated with hypoxia in the rim of the induced necrosis.
Study objective
To assess whether radiofrequency ablation in the liver is associated with
hypoxia in the rim of the induced necrosis.
Study design
Observational descriptive study, with head-to-head comparison of pre-RFA and
post-RFA uptake.
Study burden and risks
Double [18F]FAZA PET-CT scans, yielding two times 2.5 mSv for a typical FAZA
PET, low dose-CT 0.9 mSv/ acquisition. During the study, [18F]FAZA PET studies
will not be used for patient management. To compare, the natural background
radiation dose in the Netherlands is 2-2.5 mSv per year.
Our goal is to perform the [18F]FAZA PET-CT scans in 10 patients, which will
take approximately 1 year. Nonetheless, an interim analysis will be performed
after 3 patients, which will lead to a decision to continue or terminate the
study.
Postbus 7057
1007 MB Amsterdam
NL
Postbus 7057
1007 MB Amsterdam
NL
Listed location countries
Age
Inclusion criteria
*Patients with liver tumor(s) treated with percutaneous RFA
*Age > 18 years
*Written informed consent
Exclusion criteria
*Open RFA procedure for liver tumor by the surgeon
*Claustrophobia prohibiting PET-scanning
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 | NL33113.029.10 |