Pilot Feasibility Protocol of RF Ablation of Treatment of Metastatic Lesions in Patients Undergoing Antiangiogenic Therapy for Stage IV Renal Cell Carcinoma
- Participants will undergo a RF ablation procedure of one or more of their tumors that
have not gone away while they have been undergoing antiangiogenic treatment. The RF
ablation procedure will be performed in the operating room at one of the
Dana-Farber/Harvard Cancer Center hospitals and will be performed under general
- Blood will also be drawn 2-4 weeks before the procedure, at the time of teh procedure
and 2-4 weeks after the procedure.
- The RF ablation procedure will be performed at specified times in relation to the
participants antiangiogenic treatment (sorafenib or sunitinib): a) If the participant
is taking sorafenib, they will be asked to stop taking it 2-5 days prior to the RF
ablation procedure; b) if the participant is taking sunitinib, they will be asked to
stop taking it 4-7 days prior to the RF ablation procedure.
- Participants will have an MRI or a CT scan of their tumor(s) within 2-4 weeks of the
procedure and 2-4 weeks after the procedure. The MRI or CT will scan the tumor(s) to
determine how much blood flow is going to them.
- At the time of RF ablation, participants will have a biopsy of their tumor(s) and will
receive a CT scan in the area the ablation was performed after the procedure to assess
for any bleeding. They will also be monitored for 4 hours after the RF ablation
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the safety, toxicity and feasibility of RFA for the treatment of metastatic lesion in patients undergoing antiangiogenic therapy.
Rupal Bhatt, MD
Beth Israel Deaconess Medical Center
United States: Institutional Review Board
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