[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583416":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":36,"locations":46,"responsibleParty":81,"collaborators":84,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":40,"eligibilityCriteria":102,"healthyVolunteers":98,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":40,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":119,"overallStatus":124,"whyStopped":40,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"University of Massachusetts, Boston","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"To evaluate the clinical efficacy of image guided photodynamic therapy to manage HGD-OPML","EXPERIMENTAL","The participants will take 5-ALA in oral solution (20 mg\u002Fkg BW 5-ALA HCl) 2 to 4 hours prior to undergoing image guided SITOS based PDT treatment. PDT treatment will use a total light dose of 100 J\u002Fcm\\^2 of 635 nm light (red light) delivered from a laser at an irradiance of approximately 50 mW\u002Fcm\\^2 at the tissue surface. Participants will be admitted for 48 hours to monitor toxicity profile evaluation. The lesion response will be evaluated and the PDT treatment will be repeated, if required, once in every 3 weeks with a maximum of up to three sessions. The clinical responses will be evaluated during the clinical visits. If the patient shows complete clinical response in less than three sessions of PDT, the PDT will be stopped and the patients will be followed up every 3 months, for one year. If there is lack of complete response or relapse of the lesions during the follow up, the patients will be advised to undergo surgical excision.",[13],"Drug: 5-Amino Levulinic Acid",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","5-Amino Levulinic Acid","5-ALA (Gleolan) orally (20 mg\u002Fkg BW 5-ALA HCl) 2 to 4 hours prior to undergoing image-guided SITOS-based PDT treatment",[9],[21],"Gleolan",[23,27,30,33],{"name":24,"affiliation":25,"role":26},"Tayyaba Hasan, PhD","Massachusetts General Hospital, Boston, MA, United States","PRINCIPAL_INVESTIGATOR",{"name":28,"affiliation":29,"role":26},"Jonathan Celli, PhD","University of Massachusetts Boston, Boston, MA, United States",{"name":31,"affiliation":32,"role":26},"Moni A Kuriakose, MD","Karkinos Healthcare Hospitals Ernakulam, Kerala, India",{"name":34,"affiliation":35,"role":26},"Mohammad Akram, MD","Aligarh Muslim University, Aligarh, Uttar Pradesh, India",[37,42],{"name":28,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","617-287-5715",null,"jonathan.celli@umb.edu",{"name":43,"role":38,"phone":44,"phoneExt":40,"email":45},"Shakir Khan, PhD","781-350-0861","shakir.khan@umb.edu",[47,64],{"facility":48,"status":40,"city":49,"state":50,"zip":40,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Karkinos Healthcare Hospitals","Ernākulam","Kerala","India","IN",{"type":54,"coordinates":55},"Point",[56,57],76.29036,9.96714,{"lat":57,"lon":56},[60],{"name":61,"role":38,"phone":62,"phoneExt":40,"email":63},"Bharat K Sarvepalli","+91 8790469574","bharatkumar.sarvepalli@karkinos.in",{"facility":65,"status":40,"city":66,"state":67,"zip":68,"country":51,"countryCode":52,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Jawaharlal Nehru Medical College, AMU","Aligarh","Uttar Pradesh","202002",{"type":54,"coordinates":70},[71,72],78.07464,27.88145,{"lat":72,"lon":71},[75,77],{"name":34,"role":38,"phone":40,"phoneExt":40,"email":76},"akramhayat@gmail.com",{"name":78,"role":38,"phone":79,"phoneExt":40,"email":80},"M A Bilal Hussain, MSc","+91 9997657256","bilaljnmc@gmail.com",{"type":26,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"Jonathan Celli","Professor",[85,87,89,91,93],{"name":86,"class":6},"Massachusetts General Hospital",{"name":88,"class":6},"University of Arizona",{"name":90,"class":6},"Aligarh Muslim University",{"name":32,"class":92},"UNKNOWN",{"name":94,"class":95},"National Cancer Institute (NCI)","NIH","100583416","phase-2-low-cost-screening-and-image-guided-photodynamic-therapy-pdt-of-premalignant-and-malignant-oral-lesions-100583416",false,"NCT06876038","Low-cost Screening and Image-guided Photodynamic Therapy (PDT) of Premalignant and Malignant Oral Lesions","A Comprehensive Platform for Low-cost Screening and Image-guided Photodynamic Therapy (PDT) Treatment of Pre-malignant and Malignant Oral Lesions in Low-resource Setting","Subject Inclusion Criteria\n\n1. One grossly visible OPML, with histopathologically confirmed diagnosis of moderate, severe, and carcinoma in situ measuring ≥ 10 mm in diameter.\n2. Willing and available for follow-up for at least one year and at prerequisite time intervals.\n3. All patients above the age of 18 years and willing to voluntarily give a signed informed consent.\n4. Karnofsky Performance Score above 80 or ECOG 0 or 1.\n5. The subjects meeting the following laboratory eligibility criteria during a time not older than 2 months before accrual\n\n   * Hemoglobin level above or equal to 10%\n   * WBC \\>3000\u002Fmm3\n   * Platelets count \\>100000\u002Fmm3\n   * Total bilirubin, AST (SGOT), ALT (SGPT) \\\u003C 1.5 times the Upper Limit Normal\n   * eGFR \\> 60 ml\u002Fmin\n   * Serum Creatine less than 2 times the Upper Limit of laboratory normal\n   * INR\u002F PT and PTT within laboratory normal limits\n\nExclusion criteria:\n\n1. Hypersensitivity against active substances and porphyrins.\n2. Known diagnosis of porphyria.\n3. Simultaneous use of other potentially phototoxic substances (eg; tetracyclines, sulphonamides, fluoroquinolones, hypericin extracts).\n4. Uncontrolled concurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled cardiac and renal diseases or psychiatric illness.\n5. Subjects with inherited or acquired bleeding and clotting disorders\n6. Women who are breastfeeding\u002F have a positive urine pregnancy test or are planning their family.\n7. Patients who have taken supplements of retinol, beta carotene, vitamin E, Selenium, or other chemo-preventive therapy at least one month prior to the baseline visit.\n8. Patients with histological evidence of no dysplasia, mild dysplasia, invasive carcinoma, and any active malignant disease.\n9. Patients with behavioral and cognitive impairment.\n10. Patients who are concurrently diagnosed and undergoing treatment for other head and neck cancers.\n11. Patients with large lesions, which, in the investigator's opinion, may require reconstructive surgery after excision.\n12. The subjects, in the opinion of the Institutional Principal Investigator, are not an appropriate candidate for study participation due to alcoholism and abstinence.\n13. Patient who was in a clinical trial for 4 weeks before participation in the present trial.","ALL","18 Years","65 Years",{"count":107,"type":108},65,"ESTIMATED","INTERVENTIONAL",[111],"PHASE2","The primary goal of this study is to see if photodynamic therapy (PDT) is effective for treatment of lesions in the oral cavity which have high risk of becoming oral cancer. PDT treatment uses a drug, called a photosensitizer, which makes the diseased cells become light-sensitive such that they are destroyed when laser light is delivered to the target lesion. In this study a new handheld device, called SITOS (a \"Screen, Image and Treat Optical System), is used. The ability of this device to simultaneously visualize the inside of the mouth and deliver laser light to the target site will be evaluated. The main questions this study seeks to answer are:\n\n* Can this treatment completely cure oral potentially malignant lesions (OPML) without need for surgery?\n* Do lesions recur after PDT treatment?\n* Is the SITOS device easy to use for the doctor and comfortable for the patient, both as an oral imaging device and as a treatment device?",[114,115,116,117,118],"Oral Cancer","Oral Cavity Cancer","Oral Leukoplakia","Oral Lichen Planus","Oral Squamous Cell Carcinoma",[120,121,122,123],"High grade dysplasia (HGD)","Severe\u002FModerate dysplasia","Carcinoma-in-situ (CIS)","Oral potentially malignant lesion (OPML)","NOT_YET_RECRUITING","2026-03-16",{"date":127,"type":128},"2026-03-19","ACTUAL",{"date":130,"type":108},"2026-09",{"date":132,"type":108},"2028-12",{"name":5,"class":6},2]