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.
Interventional
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.
1 year
Yes
Gordon Downie, M.D., Ph.D
Principal Investigator
University of Texas Health Center at Tyler
United States: Institutional Review Board
17-00027
NCT00747916
August 2008
August 2011
Name | Location |
---|---|
University of Texas Health Center at Tyler - Titus Regional Hospital | Tyler, Texas 75702 |