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:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT02578602
Eligibility Criteria:
Inclusion Criteria:
* CT features suggestive of HCC, including those features which have been described herein; they are also enumerated below:
* For an arterially-enhancing lesion greater than or equal to 1 cm, but under 2 cm, all of the following criteria must be met:
* Imaging features of a mass
* Wash-out on later phases of contrast administration
* At least 1 cm or more growth
* For an arterially-enhancing lesion greater than or equal to 2 cm, two of the following criteria must be met:
* Imaging features of a mass
* Wash-out on later phases of contrast administration
* At least 1 cm or more growth
* All enhancing lesions with expansile, solid, enhancing tumor within vascular structures will be included, including the main portal vein, the main right and main left portal veins, the inferior vena cava (IVC), and the main hepatic veins
* No prior history of treatment of liver lesions
* Able to provide written and verbal informed consent
* Able to tolerate a complete abdominal MR examination, within 3 weeks of CT
Exclusion Criteria:
* Unable to provide written and verbal informed consent
* Unable to undergo MRI due to intraocular metallic foreign body, pacemaker, or other contraindications including objects in the body which are deemed to be unsafe or notable to be assessed, or unable to undergo MRI within 3 weeks of CT
* Pregnancy
* Severe renal insufficiency as defined by an estimated glomerular filtration rate of less than 30 cc/minute
* Severe liver disease as defined by Childs class C cirrhosis
* History of a previous reaction to contrast media
* History of bronchial asthma
* History of allergic disorders
* Acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02578602
Study Brief:
Protocol Section:
NCT02578602