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

NCT03638622 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-02-21

Study results available
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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.

Conditions

  • Oral Cancer

Interventions

COMBINATION_PRODUCT

Photodynamic Therapy

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.

Sponsors & Collaborators

  • Jawaharlal Nehru Medical College

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Tayyaba Hasan, PhD · Massachusetts General Hospital, Boston

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-10
Primary Completion
2020-10-12
Completion
2020-10-12
FDA Drug
Yes

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03638622 on ClinicalTrials.gov