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

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ClinicalTrials.gov Identifier: NCT03638622
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : August 31, 2018
Sponsor:
Collaborators:
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, disease still recurs, leading to an overall survival rate of less than 70% of these cases. The present proposal makes the case that photodynamic therapy (PDT)-based treatment of oral cancer, already shown to be effective in the traditional clinical setting, is inherently conducive to adaptation into a low-cost battery-powered platform that addresses the requirements for LMIC implementation.

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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019


Arm Intervention/treatment
Experimental: Treatment

aminolevulinic acid and photodynamic therapy

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

Combination Product: Photodynamic Therapy
Patients receive aminolevulinic acid 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 hydrochloride
  • 5 ALA HCL
  • LED based Device




Primary Outcome Measures :
  1. Tumor response [ Time Frame: 3-12 months ]
    Ultrasound of the oral cavity will be repeated to assess treatment response by lesion area (cm2) and depth (mm). Imaging at followup will be used to inform whether the patient needs full surgical excision of residual tumor by ENT surgeon and continued management as per standard of care (possibly with additional radio- and/or chemotherapy as determined by the clinical team). If no residual disease is detected, a biopsy will be conducted at the original disease site for histological confirmation of treatment response, and/or disease progression (development of invasive disease). Regardless of the flow of this study, additional follow-up on all patients will be carried out at 3 months, 6 months, 9 months and 1 year after treatment. All patient data obtained will be appropriately de-identified as per local institutional guidelines before off-site analysis, which will continue throughout the study



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
Criteria

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 patient inability to comfortably hold the light applicator in mouth.
  18. Subject has 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


Contacts
Contact: Tayyaba Hasan, PhD 6177266996 thasan@mgh.harvard.edu
Contact: Amjad Khan, PhD 7342620720 apkhan@mgh.harvard.edu

Locations
India
J.N. Medical College, Aligarh Muslim University Recruiting
Aligarh, UP, India, 202002
Contact: Shahid A Siddiqi, MD    919412273581    sasjnmc@yahoo.com   
Contact: SyedAbrar Hasan, MD    919412011993    profahasan@yahoo.com   
Sponsors and Collaborators
Massachusetts General Hospital
Jawaharlal Nehru Medical College
National Cancer Institute (NCI)
Investigators
Principal Investigator: Tayyaba Hasan, PhD Massachusetts General Hospital, Boston

Responsible Party: Tayyaba Hasan,Ph.D., Professor of Dermatology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03638622     History of Changes
Other Study ID Numbers: 2015P001855
5UH3CA189901-04 ( U.S. NIH Grant/Contract )
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

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:
Mouth Neoplasms
Lip Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Lip Diseases
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents