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 @ 3:40 AM
Ignite Modification Date:
2025-12-25 @ 3:40 AM
NCT ID:
NCT02074202
Eligibility Criteria:
Inclusion Criteria:
1. Male or female, age ≥ 20 years old.
2. Patient who accepts to enter the study by signing written informed consent.
3. Patient with performance status ≤ 2 Eastern Cooperative Oncology Group (ECOG).
4. Patient with cirrhosis or chronic liver diseases suspected to have at least 1 hepatic nodule larger than 1 cm in diameter detected by conventional image (US, CT, MRI). Patient who has not yet received any therapy relevant to the aforementioned diagnosis. Hepatic nodule is defined as any one of the following conditions: suspicious hepatocellular carcinoma, benign tumor such as hemangioma, adenoma or focal nodular hyperplasia, metastatic lesions from other primary malignancy.
5. Female patient must take reliable contraception method(s) during the participation of the study.
Exclusion Criteria:
1. Patient has serious allergic history or known allergy to 18F-FDG or 18F-FCH.
2. Patient has been diagnosed of multiple malignancies.
3. Female patient who is pregnant, lactating or planning to become pregnant during the study.
4. Patient has been participated in other investigational trials within 28 days prior to study enrollment.
5. Patient is unable to undergo PET/CT scan.
6. Subjects with active systemic infections, or medical conditions that may significantly affect action, adequate uptake and elimination of radiotracer.
7. Subject with conditions judged by the investigator as unsuitable for the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT02074202
Study Brief:
Protocol Section:
NCT02074202