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 @ 2:08 PM
Ignite Modification Date:
2025-12-24 @ 2:08 PM
NCT ID:
NCT03407495
Eligibility Criteria:
Inclusion Criteria:
1. Subjects ≥18 years of age
2. Patients with suspected HCC scheduled for partial hepatic resection.
3. Presenting with 1 to a maximum of 5 hepatic nodule(s) of equal or more than 1 cm (long axis) previously identified and characterized through multi-phase contrast enhanced CT.
4. Subjects or their partners must use a highly effective method of contraception starting from at least one menstrual cycle prior to starting study drug and till 30 days after the last dose of study drug.
Exclusion Criteria:
1. Subjects who received any previous treatment for HCC.
2. Subjects with a serious allergic history or known allergy of other contrast agent.
3. Subjects with a positive HIV test.
4. Subjects with severe renal insufficiency
5. Subjects with severe liver disease\[HCV\].
6. Subjects with active systemic infections, active and clinically significant cardiac diseases, active gastrointestinal ulcers, or medical conditions that may significantly affect action, adequate absorption, and elimination of investigational contrast agent.
7. Subject with mechanically, electrically or magnetically-activated implanted device or any metal in their body which cannot be removed.
8. Subjects who have participated in other investigational trials within 30 days prior to study enrollment.
9. Female subjects who are pregnant or breastfeeding.
10. Subjects who are clinically unstable and whose clinical course during the screening period is unpredictable.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03407495
Study Brief:
Protocol Section:
NCT03407495