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.
This is a Feasibility study to determine the safety and efficacy of a new brachytherapy device that provides unidirectional radiation which utilizes active components (Palladium-103) of standard devices in a novel configuration.This pilot study may benefit pancreatic cancer patients by reducing the radiation dose to adjacent critical structures, while giving a therapeutic dose to diseased tissue, such as at a surgical margin. The appropriate dose and local control rate will be recorded the primary endpoint in order to provide an efficacy assessment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
The 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.
Tampa General Hospital
Tampa, Florida, United States
NOT_YET_RECRUITINGRush University Cancer Center
Chicago, Illinois, United States
COMPLETEDAdvocate Christ Medical Center
Oak Lawn, Illinois, United States
Safety of CivaSheet Radiation Treatement
Patients will be monitored for any adverse radiation toxicity effects from the CivaSheet device.
Time frame: 1 Year
Efficacy of CivaSheet Radiation Treatment
Patients will be monitored for one year to determine the local cancer recurrence rate
Time frame: 1 Year
Morbidity of patients following surgery and radiation
2 year survival rates for patients post surgery and CivaSheet radiation treatment
Time frame: 2 Year
Post Operative Radiation Dosimetry Calculation
Post procedure 3D treatment planning will be performed to determine if the radiation dose delivered was satisfactory
Time frame: 1 Month
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.
Time frame: 1 Month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University Medical Center LSU
New Orleans, Louisiana, United States
COMPLETEDFox Chase Cancer Center
Philadelphia, Pennsylvania, United States
COMPLETEDVirginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
COMPLETED