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Low-cost Enabling Technology for Image-guided Photodynamic Therapy (PDT) of Oral Cancer Cancer. (UH3-India)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03638622
Recruitment Status : Completed
First Posted : August 20, 2018
Results First Posted : February 21, 2021
Last Update Posted : February 21, 2021
Jawaharlal Nehru Medical College
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Tayyaba Hasan,Ph.D., Massachusetts General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Oral Cancer Combination Product: Photodynamic Therapy Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Trial with single arm
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low-cost Enabling Technology for Image-guided Photodynamic Therapy (PDT) of Oral
Actual Study Start Date : March 10, 2017
Actual Primary Completion Date : October 12, 2020
Actual Study Completion Date : October 12, 2020

Arm Intervention/treatment
Experimental: Aminolevulinic acid (ALA) and Photodynamic Therapy (PDT)
Aminolevulinic Acid (ALA) administration, Photodynamic Therapy (PDT) treatment using LED (Light-emitting diode) light source and follow-up.
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.
Other Names:
  • Aminolevulinic acid (ALA)
  • Photodynamic Therapy (PDT)
  • Light Emitting Diode (LED) based Device

Primary Outcome Measures :
  1. Number of Participants With no Residual Tumor Following Photodynamic Therapy (PDT) [ Time Frame: Up to 2 years ]
    Histologically confirmed the absence of residual disease at follow-up lesion site biopsy (7 days) and from additional clinical examinations during follow-up visits. The follow-up visits happened approximately once every 3 months after treatment until Institutional Review Board (IRB) approval (October 12, 2020).

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03638622

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J.N. Medical College, Aligarh Muslim University
Aligarh, UP, India, 202002
Sponsors and Collaborators
Massachusetts General Hospital
Jawaharlal Nehru Medical College
National Cancer Institute (NCI)
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Principal Investigator: Tayyaba Hasan, PhD Massachusetts General Hospital, Boston
  Study Documents (Full-Text)

Documents provided by Tayyaba Hasan,Ph.D., Massachusetts General Hospital:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tayyaba Hasan,Ph.D., Professor of Dermatology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03638622    
Other Study ID Numbers: 2015P001855
5UH3CA189901-04 ( U.S. NIH Grant/Contract )
First Posted: August 20, 2018    Key Record Dates
Results First Posted: February 21, 2021
Last Update Posted: February 21, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Tayyaba Hasan,Ph.D., Massachusetts General Hospital:
Oral cancer, Photodynamic Therapy, Photosensitizer, ALA
Additional relevant MeSH terms:
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Mouth Neoplasms
Lip Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Lip Diseases
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents