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 @ 11:52 AM
Ignite Modification Date:
2025-12-24 @ 11:52 AM
NCT ID:
NCT02911961
Eligibility Criteria:
Inclusion Criteria:
* Subjects of any gender or ethnic background who are between 21 and 80 years old
* Subjects who are able to provide written, informed consent
* Subjects with secondary liver cancer
* Subjects undergoing portal vein or bland embolization for the treatment of secondary hepatic tumor
* Subjects who are willing to have their blood drawn at least 12 times for study purposes
* Subjects who agree to stay for \~18-21 hours after being discharged from the Department of Radiology for research purposes
* Subjects who agree to refrain from using acetaminophen, other than the study drug, during the dosing phase through a minimum of 5 days post-procedure
* Subjects who agree to consume less than 3 alcoholic drinks per day while taking study drug (acetaminophen group only)
* Subjects who are willing to complete a study diary for 3 days prior to and the day of the procedure
* Subjects who will be in the Denver metro area for the duration of the study
Exclusion Criteria:
* Subjects with known cirrhosis
* Subjects with a history of moderate to severe anemia at screening as defined by:
1. Moderate: Hemoglobin 8-9.5 g/dL
2. Severe: Hemoglobin \<8 g/dL
* Subjects with an ALT or AST greater than 200 IU/L at screening
* Subjects with a total bilirubin greater than 1.5 mg/dL at screening
* Subjects with an INR greater than 1.3 at screening
* Subjects with a platelet count less than 125 10\^9/L at screening
* Subjects who are currently taking warfarin (acetaminophen group only)
* Subjects with anorexia nervosa (self-reported; acetaminophen group only)
* Subjects who weigh ≤50 kg at screening (acetaminophen group only)
* Subjects who adhere to a fasting type diet (self-reported; acetaminophen group only)
* Subjects with a known hypersensitivity or allergy to acetaminophen (acetaminophen group only)
* Subjects who are currently taking isoniazid (acetaminophen group only)
* Subjects who are currently taking disulfiram (acetaminophen group only)
* Subjects who are pregnant or breastfeeding (female participants only)
* Subjects who are currently enrolled in a clinical trial, have participated in a clinical trial within the 30 days prior to the procedure, or who plan to participate in a clinical trial during the 5 day post-procedure follow-up period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT02911961
Study Brief:
Protocol Section:
NCT02911961