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:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT01686412
Eligibility Criteria:
Inclusion Criteria:
Healthy volunteers:
* Should be considered healthy, with no known relevant comorbidity.
* Patients should not be suffering from active malignancy or history of malignancy in the past.
* Must be over 18 years.
* Must have ability to understand and provide a written informed consent.
Patients with hepatocellular carcinoma:
* Patients must be diagnosed with inoperable HCC.
* Presence of primary tumor or metastatic at the time of the procedure.
* Patients with liver cirrhosis should be restricted to Child-Pugh A or B.
* Patients with AFP\> 400ng/ml and image feature does not require histopathological confirmation. However, in patients with active serology B virus, this value must be greater than AFP 4000 ng / ml. The remaining patients should have histological confirmation of HCC.
* Patients may be under observation or treatment in the presence of systemic or intra-hepatic.
* Must have ability to understand and provide a written informed consent.
Patients with Ductal Carcinoma Breast
* Patients must have a diagnosis of breast ductal carcinoma inoperable.
* The presence of the primary tumor or metastatic during the procedure.
* Patients may be under observation or in the presence of systemic or hormonal treatment only.
* Must have ability to understand to provide a written informed consent.
Exclusion Criteria:
* Can not stop antihypertensive medications or beta-blockers for at least 48 hours or being in possession of a pacemaker or other implantable device.
* Pregnant or lactating women.
* Smaller than 18 years.
* Patients undergoing radiotherapy treatment or up to 2 weeks of discontinuation.
* Inability to understand and provide written informed consent.
* Liver cirrhosis Child Pugh C.
* Patients without a definite diagnosis.
* Absence of the primary tumor or metastatic during the procedure.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01686412
Study Brief:
Protocol Section:
NCT01686412