A Novel Therapy for the Treatment of Chest Wall Progression of Breast Cancer
|ClinicalTrials.gov Identifier: NCT01262716|
Recruitment Status : Completed
First Posted : December 17, 2010
Last Update Posted : October 25, 2011
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||3 participants|
|Official Title:||A Novel Therapy for the Treatment of Chest Wall Progression of Breast Cancer|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|