Status:
COMPLETED
Photodynamic Therapy (PDT) in Lung Cancer
Lead Sponsor:
Mayo Clinic
Conditions:
Lung Cancer
Eligibility:
All Genders
50-75 years
Phase:
NA
Brief Summary
This study is being done to determine whether a substance called hematoporphyrin can be used to treat tumors in various locations in the body when used in association with a laser. Hematoporphyrin is ...
Detailed Description
Lung cancer is currently the leading cause of death in both women and men in the United States and continues to be a major problem in several other countries in the world. Detection, localization, and...
Eligibility Criteria
Inclusion
- Patient less than 75 years of age.
- Squamous cell lung cancer proven by biopsy or repeated Brushings obtained from the same location at separate bronchoscopies.
- Occult lung cancer by chest roentgenogram and CT scan If CT scan is abnormal, mediastinoscopy is negative.
- Cancer is bronchoscopically superficial as defined in section IV, E.
- Estimated size less than 1 cm diameter on the surface of the bronchus with the surface area of 0.7 to 1.0 cm2.
- Location in the trachea, main stem bronChi, lobar bronchi, segmental bronchi, or subsegmental bronchi.
- Medical condition permits surgery: cardiovascular status is satisfactory for operation and postoperative FEVl is predicted to be greater than 0.75 liter.
- Patients will complete quality of life questionnaire and a spirometry which will include forced expiratory volume in 1 second (FEVl) and forced vital capacity (FVC).
- On bronchoscopic biopsy, the carcinoma is entirely in situ or shows no more than 2 mm of microinvasion.
- The characteristics of the mucosa. may include paleness, opacity, loss of luster, roughness, micro-granularity.
- The mucosal folds may demonstrate lack of clarity. thickening, disappearance.
- There may be small nodular protrusion of tumor into the lumen
- The peripheral extent of tumor invasion can be confirmed endoscopically.
Exclusion
- A medical disease which excludes surgery as an option
- A postoperative FEVl predicted to be less than 0.75 liter
- A previous carcinoma or other malignancy not curatively treated
- The presence of simultaneous lung cancers
- CT scan of the chest shows thickening of the bronchial wall or extension beyond the bronchial wall in the area of the cancer
Key Trial Info
Start Date :
February 1 1994
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00984243
Start Date
February 1 1994
End Date
October 1 2006
Last Update
November 15 2012
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905