A Novel Therapy for the Treatment of Chest Wall Progression of Breast Cancer
This study will assess safety and ergonomics/engineering design of a novel cancer treatment, Continuous Low Irradiance Photodynamic therapy (CLIPT). We will assess the effects on primary and metastatic tumors involving the skin, in particular to improve the functionality, efficiency and wearability of the light delivery device (LDD) as well as the overall treatment in subjects with chest wall recurrences of breast cancer. An ongoing study (IRB# 8227), sponsored by a Susan G. Komen Breast Cancer Foundation grant, using a 1st generation LDD device has evaluated and determined a dose-limiting toxicity of CLIPT for subjects with chest wall recurrences of breast cancer.
A Diomed laser will be the device used in this study. The Diomed laser will deliver 630 nm (red spectrum) light through a Fiber Optic Patch. The Fiber Optic patch will be compatible with the laser, delivering light to a designated region on the patient's skin.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A Novel Therapy for the Treatment of Chest Wall Progression of Breast Cancer|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262716
|United States, Massachusetts|
|Tufts Medical Center|
|Boston, Massachusetts, United States, 02111|
|Study Director:||Gary S. Rogers, M.D.||Rogers Sciences Inc.|
|Principal Investigator:||Roger A. Graham, M.D.||Tufts Medical Center|