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 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT00601120
Eligibility Criteria:
Inclusion Criteria:
* Patients who are on antiangiogenic therapy for a minimum of 4 weeks and have isolated metastatic lesions showing either persistence or resistance to therapy that might benefit from local therapy such as RF ablation.
* Male or female patients 18 years of age or older
* Clinical, radiographic, or pathologic diagnosis of clear cell RCC
* Ongoing treatment with sorafenib or sunitinib, off clinical trials
* Acceptable risk for general anesthesia in the judgement of the study investigator and by the department of anesthesiology upon preoperative testing.
* At least one lesion that has not completely resolved while on antiangiogenic therapy
* Candidate lesions of 1cm or greater in diameter
* Safe access to the tumor for a needle placed under ultrasound guidance
* ECOG Performance Status of 0 or 1
* Adequate bone marrow, and renal as assessed by the laboratory requirements outlined in the protocol
Exclusion Criteria:
* History of bleeding diathesis or unexpected surgical bleeding
* Patients currently on anticoagulation
* Medical contraindication to MR imaging (pacemaker, metal debris in eye, etc.)
* Prior RF to the index tumor
* Pregnant or lactating
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00601120
Study Brief:
Protocol Section:
NCT00601120