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 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT03448757
Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteers
* Must be considered healthy, with no known relevant comorbidity.
* Patients must not be carriers of active malignant neoplasm or have a history of malignant neoplasm.
* Must be over 18 years old.
* Must have the ability to understand and provide written Informed Consent.
Patients with hepatocellular carcinoma
* Patients must be diagnosed with inoperable HCC.
* Presence of the primary or metastatic tumor at the time of the procedure.
* Patients diagnosed with hepatic cirrhosis must be restricted to Child-Pugh A or B.
* Patients with AFP\> 400 ng/ml and characteristic image do not need histopathological confirmation. However, in patients with serology for active B virus, this AFP value must be greater than 4000 ng/ml. The remaining patients must have histological confirmation of HCC.
* Patients may be in observation or in the course of systemic or intra-hepatic treatment.
* Must have the ability to understand and provide written Informed Consent.
Exclusion Criteria:
* Individuals selected for this study will be excluded if they meet the following exclusion criteria:
* They cannot stop antihypertensive drugs or beta blockers for at least 24 hours.
* Have a pacemaker or other implantable device.
* Pregnant or breastfeeding.
* Under the age of 18.
* Patients undergoing radiotherapy or up to 2 weeks after its suspension.
* Inability to understand and provide written Informed Consent.
* Child Pugh C hepatic cirrhosis.
* Patient without definite diagnosis.
* Absence of primary or metastatic tumor at the time of the procedure.
Potentially eligible participants will be previously guided by the researcher on the objectives and risks of the study in question and will be presented and informed about the Free, Prior and Informed Consent document.
Only after all doubts related to the study have been clarified and the Free, Prior and Informed Consent document has been signed, will the study participant be invited and scheduled to attend the Oncology Center clinic of Hospital Sírio Libanês.
Patients must be informed that they may not drink alcohol up to 12 hours before the procedure, as there may be interference during the procedure.
They will also be advised not to use antihypertensive drugs like beta-blockers or calcium channel inhibitors 24 hours before the procedure, without resulting in a risk to the participant's health.
In this study, following or follow-up of patients is not foreseen.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03448757
Study Brief:
Protocol Section:
NCT03448757