CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Photodynamic Therapycombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03638622
NCT03638622Phase 2Completed

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

Massachusetts General Hospital·interventional·Posted Aug 20, 2018·Updated Feb 21, 2021

In Brief

A Phase 2 clinical trial evaluating Photodynamic Therapy for Oral Cancer. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOral Cancer
CountriesIndia

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 20, 2018
Enrollment StartMar 10, 2017
Primary CompletionOct 12, 2020
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 7.9 years ago

Interventions

Photodynamic Therapycombination

Patients receive aminolevulinic acid (ALA) orally with orange juice in 3 fractions at 0,1,2 hours before undergoing photodynamic therapy using LED based Device on day one.