Low-cost Enabling Technology for Image-guided Photodynamic Therapy (PDT) of Oral
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of Participants With no Residual Tumor Following Photodynamic Therapy (PDT)
研究概览
简要总结
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.
详细描述
Study Facility:
Pre-study Screening: Patients come to Ear, Nose, and Throat (ENT)/Oral and Maxillofacial/Plastic and Reconstructive surgery outpatient facilities. Typically, an ENT specialist handles early cases (biopsy proven malignancies), while ENT and plastic surgeons jointly deal with advanced cases. Patients screening will take place in outpatient departments. The investigator/s will interview each subject to develop a brief, relevant medical history and determine that all selection criteria are met. The subject will receive an explanation of the study objectives, possible risks and benefits of the study. After history evaluation of the patients, Blood work will be done to check liver functions Test. After the blood report and inclusion and exclusion criteria, the consultant will discuss and educate the patients about photosensitization and Photodynamic Therapy (PDT). If patients are willing to take part in the study, co-investigator will obtain a signed consent form. After obtaining a signed consent form, the consultant will schedule an appointment for PDT therapy.
Procedure after enrollment: Investigators plan to enroll 30 patients with oral cancer in this study. The study will take place at Jawaharlal Nehru Medical College (JNMC), Aligarh. This timeline of procedures considers that many patients may need to travel from remote rural areas with poor access to transportation, so it cannot be assumed that patients have convenient access to return to the clinic for multiple repeated biopsies.
Aminolevulinic Acid (ALA) preparation and administration: The FDA-approved Aminolevulinic Acid (ALA) from Dusa Pharmaceuticals, Inc., Wilmington, Massachusetts (MA) will be used in powder form. Patients will initially receive a baseline ultrasound of the oral cavity prior to ALA administration. In the case of potentially childbearing women, a serum pregnancy test will be performed before ALA administration by SD (Standard Diagnostic Inc, India) Bioline kit. One hour prior to ALA administration, analgesic (Aceclofenac 200mg, Intas Pharmaceuticals, India), anti-inflammatory drug (HifenacSR 200mg; Intas Pharmaceuticals, India) and antiemetic (Domperidone, Domperon, 10mg; Cadila Pharmaceuticals, Inc., India) will be given to patients orally to avoid nausea and pain. ALA, totaling 60 mg/kg, will be administered orally via three repeated doses of 20 mg/kg of ALA dissolved in either orange juice or a soft drink, which lowers the potential of hydrogen (pH) of the solution, at 0, 1 and 2 hours.
Day One: Baseline imaging; Fluorescence measurement: PpIX (Protoporphyrin IX) fluorescence will be recorded using 405nm excitation light delivered from an Light-Emitting Diode (LED) source powered by a smartphone. This is a non-invasive system. The PpIX fluorescence will be photographed using the camera embedded in the smartphone. The advantage of this step is that in the long term it will obviate the need for biopsies to establish PpIX concentrations and could allow for online dosimetry customized to individual patients. Three photographs will be taken in each subject: first photograph will be taken prior to given ALA to the patients, second photograph after 2-3 hours of ALA incubation, and third photograph will be taken immediately after PDT treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Number of Participants With no Residual Tumor Following Photodynamic Therapy (PDT)
时间窗: 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).
次要结局
未报告次要终点
研究者
Tayyaba Hasan,Ph.D.
Professor of Dermatology
Massachusetts General Hospital