Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT01473004
Eligibility Criteria:
Inclusion Criteria:
* must have diagnosis of metastatic melanoma liver disease by histological confirmation
* one measurable untreated or progressed liver lesion
* less than 50% liver involvement
* must have ECOG performance status of 0-1
* must have adequate renal and bone marrow function as: serum creatinine ≤ 2.0 mg/dl, granulocyte count ≥1000/mm3 and platelet count ≥100,000/mm3
* must have adequate liver function as: total bilirubin \<1.6 mg/ml and albumin \>3.0 g/dl
Exclusion Criteria:
* failure to meet any of the inclusion criteria
* solitary liver metastasis that is amenable to surgical removal
* previous treatment with isolated hepatic perfusion
* systemic chemotherapy within 2 weeks of study entry
* significant shunting to the lung (\>20%) as identified on Technetium-99m-macro-aggregated albumin nuclear medicine break-through scan
* unsuccessful closure of collateral blood flows from the hepatic artery to non-targeted organs such as the GI tract
* symptomatic liver failure including ascites and hepatic encephalopathy
* metastasis outside of liver requiring systemic treatment within 3 months
* untreated brain metastasis
* main portal vein occlusion or inadequate collateral flow
* uncontrolled hypertension or congestive heart failure
* acute myocardial infarction within 6 months
* medical complications with implication of less than 6 month survival
* uncontrolled severe bleeding tendency or active GI bleed
* significant allergic reaction to iodinated contrast
* previous radiation that includes the liver in the main radiation field
* pregnant or breast-feeding women
* biliary obstruction, stent, or prior biliary surgery including sphincterotomy but excluding cholecystectomy
* children under the age of 18
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01473004
Study Brief:
Protocol Section:
NCT01473004