Initial study to evaluate local control and the preferred method of attachment of the CivaSheet in the setting of suspected close or positive margins at the time of surgical tumor removal.
• Subject signed inform consent
Age > 18 years
Not pregnant or breast feeding
Patient capable of undergoing anesthesia
Not surgical candidate
Any other invasive cancer in the past 5 years, except basal cell or squamous cell skin cancer
An IRE candidate (IRE is Percutaneous irreversible electroporation)
Recurrent or previously resected tumors
Single group
Directional Brachytherapy Source Implant
DeviceThe FDA Cleared CivaSheet Directional Pd103 Brachytherapy Source is a planar radiaiton source which utilizes gold shielding in its construction. This device is radioactive on one side only, and is capable of safely delivering high doses of radiation to target areas even when placed directly adjacent to sensitive, healthy tissue or critical structures.
Safety of CivaSheet Radiation Treatement
Patients will be monitored for any adverse radiation toxicity effects from the CivaSheet device.
Efficacy of CivaSheet Radiation Treatment
Patients will be monitored for one year to determine the local cancer recurrence rate
Morbidity of patients following surgery and radiation
2 year survival rates for patients post surgery and CivaSheet radiation treatment
Post Operative Radiation Dosimetry Calculation
Post procedure 3D treatment planning will be performed to determine if the radiation dose delivered was satisfactory
Length of Hospital Stay
Length of hospital stay will be monitored to determine if CivaSheet radiation treatment alters the typical length of hospital stay for patients after surgery.
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