Hepatocellular Carcinoma Clinical Trial
Official title:
Value of Pretreatment MRI Determined Parameters for Predicting Outcome After Radio-frequency Ablation of Hepatocellular Carcinoma
Verified date | January 2014 |
Source | Universitaire Ziekenhuizen Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | Belgium: Ethics Committee |
Study type | Observational |
HCC is classified as keratin (K) 19 positive or K19 negative. K19 is a biliary/hepatic
progenitor cell (HPC) marker only expressed in a subset of HCC with poor prognosis and high
risk of early recurrence after treatment; particularly in radio-frequency ablation (RFA).
These patients consequently show worse survival compared to patients with K19 negative HCC.
A recent publication has shown the value of pretreatment biopsy with K19 staining and
suggests that the role of routine biopsies in potentially curable HCC should be
reconsidered.
However, currently, pretreatment biopsies are rarely performed in the diagnosis of HCC due
to the excellent performance of magnetic resonance imaging (MRI) in detection, diagnosis and
staging of cirrhotic livers.
Previous publications have indicated imaging patterns that may be associated with worse
prognostic tumoral parameters.
If MRI determined imaging parameters could indeed provide a surrogate marker for presence of
K19 and/or microvascular invasion as potential important prognostic factors in RFA of HCC,
these imaging parameters may thus hold prognostic information towards RFA treatment and
possibly predict treatment outcome. .
The purpose of the retrospective study is thus to evaluate MRI determined imaging parameters
at pretreatment MRI for their predictive value towards outcome (disease free survival) of
radio-frequency ablation for hepatocellular carcinoma.
If successful, pretreatment MRI parameters may be used for selecting patient with high risk
of unfavorable outcome after RFA and select the patients for more aggressive treatment such
as surgical resection or upfront transplantation.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Documented and diagnosed liver confined hepatocellular carcinoma by existing imaging criteria according to currently accepted international guidelines (< 4cm). - Treatment radio-frequency ablation - (percutaneous, laparascopy, laparatomy) - Availability of pretreatment MRI with three phase contrast enhanced images and diffusion-weighted sequence prior to treatment. - Follow-up of at least 2 years. Exclusion Criteria: - Non availability of pathologic confirmation or biopsy during radio-frequency ablation. - Post-treatment follow-up < 2 years. - Treatment other than RFA |
Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospitals UZ Leuven, Gasthuisberg | Leuven | Vlaams-Brabant |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen Leuven |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Predictive value of MRI determined contrast-enhanced and diffusion-weighted sequence pattern towards outcome (tumour recurrence < 1 year versus > 1 year) | Predictive value of MRI determined contrast-enhanced and diffusion-weighted sequence pattern towards outcome (tumour recurrence < 1 year versus > 1 year) | 2 years | No |
Secondary | Correlation of predictive MRI parameters with histology obtained from biopsy during radio-frequency ablation (tumor grade, microvascular invasion, Keratin 19 status) | Correlation of predictive MRI parameters with histology obtained from biopsy during radio-frequency ablation (tumor grade, microvascular invasion, Keratin 19 status) | 2 years | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04209491 -
Interest of the Intervention of a Nurse Coordinator in Complex Care Pathway
|
||
Completed |
NCT03963206 -
Cabozantinib toLERANCE Study in HepatoCellular Carcinoma (CLERANCE)
|
Phase 4 | |
Completed |
NCT03268499 -
TACE Emulsion Versus Suspension
|
Phase 2 | |
Recruiting |
NCT05044676 -
Immune Cells as a New Biomarker of Response in Patients Treated by Immunotherapy for Advanced Hepatocellular Carcinoma
|
||
Recruiting |
NCT05263830 -
Glypican-3 as a Prognostic Factor in Patients With Hepatocellular Carcinoma Treated by Immunotherapy
|
||
Recruiting |
NCT05095519 -
Hepatocellular Carcinoma Imaging Using PSMA PET/CT
|
Phase 2 | |
Recruiting |
NCT05497531 -
Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers
|
N/A | |
Completed |
NCT05068193 -
A Clinical Trial to Compare the Pharmacokinetics and Bioequivalence of "BR2008" With "BR2008-1" in Healthy Volunteers
|
Phase 1 | |
Active, not recruiting |
NCT03781934 -
A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations
|
Phase 1/Phase 2 | |
Terminated |
NCT03655613 -
APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04242199 -
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT04401800 -
Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma
|
Phase 2 | |
Withdrawn |
NCT05418387 -
A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona
|
N/A | |
Active, not recruiting |
NCT04039607 -
A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma
|
Phase 3 | |
Terminated |
NCT03970616 -
A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma
|
Phase 1/Phase 2 | |
Recruiting |
NCT04118114 -
Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors
|
Phase 2 | |
Recruiting |
NCT06239155 -
A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03642561 -
Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE
|
Phase 2/Phase 3 | |
Completed |
NCT03222076 -
Nivolumab With or Without Ipilimumab in Treating Patients With Resectable Liver Cancer
|
Phase 2 |