The primary goal of this study is to see if photodynamic therapy (PDT) is effective for treatment of lesions in the oral cavity which have high risk of becoming oral cancer. PDT treatment uses a drug, called a photosensitizer, which makes the diseased cells become light-sensitive such that they are destroyed when laser light is delivered to the target lesion. In this study a new handheld device, called SITOS (a "Screen, Image and Treat Optical System), is used. The ability of this device to simultaneously visualize the inside of the mouth and deliver laser light to the target site will be evaluated. The main questions this study seeks to answer are:
* Can this treatment completely cure oral potentially malignant lesions (OPML) without need for surgery? * Do lesions recur after PDT treatment? * Is the SITOS device easy to use for the doctor and comfortable for the patient, both as an oral imaging device and as a treatment device?
Willing and available for follow-up for at least one year and at prerequisite time intervals.
All patients above the age of 18 years and willing to voluntarily give a signed informed consent.
Karnofsky Performance Score above 80 or ECOG 0 or 1.
The subjects meeting the following laboratory eligibility criteria during a time not older than 2 months before accrual
Hypersensitivity against active substances and porphyrins.
Known diagnosis of porphyria.
Simultaneous use of other potentially phototoxic substances (eg; tetracyclines, sulphonamides, fluoroquinolones, hypericin extracts).
Uncontrolled concurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled cardiac and renal diseases or psychiatric illness.
Single group
5-Amino Levulinic Acid
Drug5-ALA (Gleolan) orally (20 mg/kg BW 5-ALA HCl) 2 to 4 hours prior to undergoing image-guided SITOS-based PDT treatment
Efficacy of 5-ALA based PDT to treat HGD-OPML
The response will be clinically evaluated three weeks after PDT treatment. It will be defined as complete, partial, stable or progressive disease by modified RECIST criteria.
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University of Massachusetts, Boston
Lead sponsor
Massachusetts General Hospital
Collaborator
University of Arizona
Collaborator
Aligarh Muslim University
Collaborator
Karkinos Healthcare Hospitals Ernakulam, Kerala, India
Collaborator
National Cancer Institute (NCI)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
