Prospective Follow-up of Outcomes in Patients Receiving Photodynamic Therapy for Neoplastic Diseases

From 1996-present, we have used photodynamic therapy (PDT) to treat a number of neoplastic
diseases both on prospective research protocols (for head and neck cancer, pleural
malignancies, peritoneal carcinomatosis or sarcomatosis and prostate cancer) as well as for
FDA approved and off label or compassionate exemption indications (neoplasms of the skin,
bronchus, esophagus, head and neck and pleura). The goal of this treatment is to maximize
quality of life and organ function while minimizing the chance of tumor recurrence. As such,
we would like to retrospectively review the treatment parameters of all patients who
undergo/underwent PDT (including operative notes and photodynamic therapy records) and
treatment outcomes (including all organ functions, performance status, tumor recurrence,
laboratory values and any other data present in the routinely documented follow up visits).
For patients who have died or were lost to follow-up prior to initiation of this study, a
retrospective review of available data will be performed. For patients who are still being
actively followed after PDT or who receive PDT after the initiation of this study, informed
consent will be obtained for obtaining continued follow-up data prospectively and any
previous data will be collected retrospectively.. These subjects will continue to receive
care from their current physicians according to standard medical practice and no attempt
will be made to alter the types of follow-up, radiologic or other diagnostic studies or
medical treatment as a result of enrollment in this study. All data will be de-identified
and added to our already existing PDT treatment outcome databases for outcomes analysis,
quality improvement and reporting of results in abstract and manuscript forms.