Patient's with High Grade Dysplasia, Carcinoma in situ or Early Adenocarcinoma in Barrett's Esophagus are injected with HPPH and one day later are endoscopically treated with light from a laser.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
3mg/m2 or 4 mg/m2 at light doses of 150, 175 and 200 joules/cm
Roswell Park Cancer Institute
Buffalo, New York, United States
Optimal Light Dose
Using toxicity to normal surrounding tissue as a determinant and using two HPPH doses of PDT in HGD, CIS or early adenocarcinoma in Barrett's esophagus, to determine the optimal light dose at each HPPH dose
Time frame: 24 hours
Toxicity to normal surrounding tissue
To determine the tocixity to normal surrounding tissue of treating at approximately 24 hours(21-26hr) post injection of HPPH
Time frame: 24 hours
Comparing HPPH to Photofrin
To determine the length of time of cutaneous photosensitivity of HPPH compared to historical data on Photofrin
Time frame: 5 years
Effect of injection
To determine the effect of a 24 hours interval between injection of HPPH and light treatment
Time frame: 24 hours
Efficacy of Treatment
A secondary objective is to determine efficacy of treatment at each set of paraments, i.e. ability to completely resolve the CIS, HGD or early cancer.
Time frame: 5 years
Resolve Barrett's mucosa
An Additional secondary objective is to determine ability of PDT to resolve the Barrett's mucosa
Time frame: 5 years
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