Low-cost Enabling Technology for Image-guided Photodynamic Therapy (PDT) of Oral Cancer Cancer.

Inclusion Criteria:

1. Age above 21 years, males or females
2. Subject has read and signed a written informed consent form
3. Subject is willing to have ALA administered and wait for 2-3 hours
4. Subject is willing to receive red light irradiation in the mouth via the fiber probe/applicator and is willing to have the fiber probe/applicator in the mouth for a maximum time of 1 hour
5. Subject is willing to allow investigators to take measurements using smart phone imaging before, during and after light treatment
6. After the procedure, the subject is willing to avoid spicy, hot, or oily foods for at least 6 hours
7. Subject willing to wear full sleeve shirt and full-length garments for couple of hours

Exclusion Criteria:

1. Pregnancy or nursing (ALA is a drug that belongs to FDA pregnancy category C).
2. History of photosensitivity diseases (e.g., lupus erythematosus, porphyrias).
3. Therapy with any photosensitizing medication, e.g., thiazides (for the treatment of high blood pressure), fluoroquinolones, griseofulvin, or sulfonamides (for the treatment of infections), sulfonylureas (for the treatment of diabetes), phenothiazines (for the treatment of emotional problems), and other medications reported to cause photosensitivity within the last 6 months.
4. Subject is unable or unwilling to comply with the study requirements.
5. Subject has any conditions or scars within the location of the test sites that may interfere with the treatment or evaluation.
6. Allergy to porphyrins or ALA.
7. Subject has received laser treatment within 6 months in the area of the treatment.
8. Subject is participating in other potentially confounding research, e.g., currently enrolled in a clinical study of any other unapproved investigational drug or device.
9. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study.
10. Subject has inadequate organ function.
11. Subject has co-morbid systemic illnesses or severe concurrent disease.
12. Subject is being treated for vascular disease.
13. Subject is an employee of the participating sites directly supervised by the investigator.
14. Subject with invasive deep carcinoma evaluated by biopsy.
15. Subject is currently being treated for other cancers with medical or radiation therapy.
16. Subject has AIDS or other infectious diseases, including tuberculosis, hepatitis or herpetic lesions (oral herpes).
17. Subject has oral submucous fibrosis (OSF) resulting in a patient inability to comfortably hold the light applicator in mouth.
18. Subject has Human papillomavirus (HPV) positive tumor.
19. Subject has the tumor at Oropharynx area.
20. We will excludes the patients of the all other oral lesions at sites except: the gingivobuccal sulcus, cheek, floor of the mouth and tongue.