A Pilot Study of the Safety, Efficacy, and Side Effects of Interventional Cryotherapy for the Eradication of Disease in the Pleural Space ("ICE PLS")
The proposed study is a pilot study consisting of an estimated 10 subjects with
biopsy-proven metastatic cancer in the parietal pleural surface treated with CryoSpray at
dye marked metastatic foci.
Initial treatment dosimetry will be up to 3 cycles of 10-40 second sprays. If necessary,
dosimetry changes may occur after 3 subjects are treated and observed. It is unknown if
dosimetry will need to be increased to enhance effectiveness. The PI may increase dosimetry
by 1 cycle after each subject is treated and observed as a conservative approach to efficacy
determination. If disease exists bilaterally, only one side will be sprayed.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To reduce tumor burden in the pleural space, as determined by visual inspection and biopsy of the treatment sites 2-5 days post treatment. Safety endpoint clinical and radiographic status at 30 days post CryoSpray treatment and adverse events.
Gordon Downie, M.D., Ph.D
University of Texas Health Center at Tyler
United States: Institutional Review Board
|University of Texas Health Center at Tyler - Titus Regional Hospital||Tyler, Texas 75702|