Phase 2 N=30 Treatment

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

Oral Cancer

Bottom Line

View on ClinicalTrials.gov: NCT03638622 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2021

Primary outcome: Primary: Number of Participants With no Residual Tumor Following Photodynamic Therapy (PDT) — 22 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Photodynamic Therapy (Combination_product)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Oct 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With no Residual Tumor Following Photodynamic Therapy (PDT)	22	—

Summary

Oral cancer in India affects mostly those from the lower socioeconomic groups, due to a higher exposure to risk factors such as the use of tobacco, zarda, khaini, chewing gutka, mawa, and kharra, which are all dry mixtures of flavorings, areca nut flakes and powdered tobacco. Earlier detection of oral cancer offers the best chance for long-term survival and has the potential to improve treatment outcomes and make healthcare affordable. Current treatment options, primarily surgery and/or radiation, can be curative if cancer or dysplasia is caught at a sufficiently early stage. Though even in these cases treatment may be disfiguring with significant impact upon quality of life, and many patients do not seek medical attention until the disease has progressed to a point where radical operation is required (Stage III/IV), often entailing block dissection and removal of the entire lymphatic drainage of the neck. Despite the radical operation, the disease still recurs, leading to an overall survival rate of less than 70% of these cases. The present study evaluates photodynamic therapy (PDT) as an alternative intervention for early-stage malignant lesions of the oral cavity using a low-cost and battery-powered platform that is specifically adapted for low and middle-income countries (LMIC) implementation.

Eligibility Criteria

Inclusion Criteria

Age above 21 years, males or females
Subject has read and signed a written informed consent form
Subject is willing to have ALA administered and wait for 2-3 hours
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
Subject is willing to allow investigators to take measurements using smart phone imaging before, during and after light treatment
After the procedure, the subject is willing to avoid spicy, hot, or oily foods for at least 6 hours
Subject willing to wear full sleeve shirt and full-length garments for couple of hours

Exclusion Criteria

Pregnancy or nursing (ALA is a drug that belongs to FDA pregnancy category C).
History of photosensitivity diseases (e.g., lupus erythematosus, porphyrias).
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.
Subject is unable or unwilling to comply with the study requirements.
Subject has any conditions or scars within the location of the test sites that may interfere with the treatment or evaluation.
Allergy to porphyrins or ALA.
Subject has received laser treatment within 6 months in the area of the treatment.
Subject is participating in other potentially confounding research, e.g., currently enrolled in a clinical study of any other unapproved investigational drug or device.
Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study.
Subject has inadequate organ function.
Subject has co-morbid systemic illnesses or severe concurrent disease.
Subject is being treated for vascular disease.
Subject is an employee of the participating sites directly supervised by the investigator.
Subject with invasive deep carcinoma evaluated by biopsy.
Subject is currently being treated for other cancers with medical or radiation therapy.
Subject has AIDS or other infectious diseases, including tuberculosis, hepatitis or herpetic lesions (oral herpes).
Subject has oral submucous fibrosis (OSF) resulting in a patient inability to comfortably hold the light applicator in mouth.
Subject has Human papillomavirus (HPV) positive tumor.
Subject has the tumor at Oropharynx area.
We will excludes the patients of the all other oral lesions at sites except: the gingivobuccal sulcus, cheek, floor of the mouth and tongue.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03638622). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.