Photodynamic Therapy (PDT) With Temoporfin for Non-Resectable Non-Small-Cell Lung Cancer
The purpose of this study is to evaluate the safety of I-PDT with Temoporfin for patients with Non-Resectable Non-Small-Cell Lung Cancer (NR-NSCLC). Several clinical studies suggested that photodynamic therapy (PDT) may be an effective treatment for patients with NR-NSCLC. PDT is a therapy where an external light source, such as laser, is used to activate a light-sensitive medicine to produce byproducts that can destroy cancer cells. In this study the investigators will use an experimental light sensitive medicine, Temoporfin, to perform interstitial PDT (I-PDT). In I-PDT, laser fibers are inserted into the tumor to activate the light-sensitive medicine.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Photodynamic Therapy (PDT) With Temoporfin for Non-Resectable Non-Small-Cell Lung Cancer|
- Occurrence of serious adverse events [ Time Frame: 14 and 30 days post-therapy ] [ Designated as safety issue: Yes ]The specific aim of this pilot study is to evaluate the safety of CT-guided I-PDT with Temoporfin on patients with NR-NSCLC. Patient safety will be the primary endpoint. The safety of the intervention will be assessed at 14 and 30 days post-therapy. The primary outcome will be occurrence of Serious Adverse Events (SAE).
|Study Start Date:||July 2012|
|Study Completion Date:||January 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637376
|United States, Arkansas|
|University of Arkansas for Medical Sciences|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||Mary E Meek, MD||University of Arkansas|