Low-cost Screening and Image-guided Photodynamic Therapy (PDT) of Premalignant and Malignant Oral Lesions

NCT06876038 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: CA279862U01CA279862
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

Brief Summary

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:

• Can this treatment completely cure oral potentially malignant lesions (OPML) without need for surgery?
• Do lesions recur after PDT treatment?
• 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?

Conditions

Oral Cancer; Oral Cavity Cancer; Oral Leukoplakia; Oral Lichen Planus; Oral Squamous Cell Carcinoma

Keywords

High grade dysplasia (HGD); Severe/Moderate dysplasia; Carcinoma-in-situ (CIS); Oral potentially malignant lesion (OPML)

Outcome Measures

Primary Outcomes (1)

• Efficacy of 5-ALA based PDT to treat HGD-OPML

  The response will be clinically evaluated three weeks after PDT treatment. It will be defined as complete, partial, stable or progressive disease by modified RECIST criteria.

  3 weeks after PDT treatment

Study Arms (1)

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/kg 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/cm\^2 of 635 nm light (red light) delivered from a laser at an irradiance of approximately 50 mW/cm\^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.

Drug: 5-Amino Levulinic Acid

Interventions

5-Amino Levulinic Acid DRUG

5-ALA (Gleolan) orally (20 mg/kg BW 5-ALA HCl) 2 to 4 hours prior to undergoing image-guided SITOS-based PDT treatment

Also known as: Gleolan

To evaluate the clinical efficacy of image guided photodynamic therapy to manage HGD-OPML

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• One grossly visible OPML, with histopathologically confirmed diagnosis of moderate, severe, and carcinoma in situ measuring ≥ 10 mm in diameter.
• Willing and available for follow-up for at least one year and at prerequisite time intervals.
• All patients above the age of 18 years and willing to voluntarily give a signed informed consent.
• Karnofsky Performance Score above 80 or ECOG 0 or 1.
• The subjects meeting the following laboratory eligibility criteria during a time not older than 2 months before accrual
• Hemoglobin level above or equal to 10%
• WBC \>3000/mm3
• Platelets count \>100000/mm3
• Total bilirubin, AST (SGOT), ALT (SGPT) \< 1.5 times the Upper Limit Normal
• eGFR \> 60 ml/min
• Serum Creatine less than 2 times the Upper Limit of laboratory normal
• INR/ PT and PTT within laboratory normal limits

You may not qualify if:

• Hypersensitivity against active substances and porphyrins.
• Known diagnosis of porphyria.
• Simultaneous use of other potentially phototoxic substances (eg; tetracyclines, sulphonamides, fluoroquinolones, hypericin extracts).
• 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.
• Subjects with inherited or acquired bleeding and clotting disorders
• Women who are breastfeeding/ have a positive urine pregnancy test or are planning their family.
• 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.
• Patients with histological evidence of no dysplasia, mild dysplasia, invasive carcinoma, and any active malignant disease.
• Patients with behavioral and cognitive impairment.
• Patients who are concurrently diagnosed and undergoing treatment for other head and neck cancers.
• Patients with large lesions, which, in the investigator's opinion, may require reconstructive surgery after excision.
• The subjects, in the opinion of the Institutional Principal Investigator, are not an appropriate candidate for study participation due to alcoholism and abstinence.
• Patient who was in a clinical trial for 4 weeks before participation in the present trial.

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• University of Massachusetts, Boston: lead
• Massachusetts General Hospital: collaborator
• University of Arizona: collaborator
• Aligarh Muslim University: collaborator
• Karkinos Healthcare Hospitals Ernakulam, Kerala, India: collaborator

Study Sites (2)

Karkinos Healthcare Hospitals

Ernākulam, Kerala, India

Location

Jawaharlal Nehru Medical College, AMU

Aligarh, Uttar Pradesh, 202002, India

Location

Related Publications (1)

• Siddiqui SA, Siddiqui S, Hussain MAB, Khan S, Liu H, Akhtar K, Hasan SA, Ahmed I, Mallidi S, Khan AP, Cuckov F, Hopper C, Bown S, Celli JP, Hasan T. Clinical evaluation of a mobile, low-cost system for fluorescence guided photodynamic therapy of early oral cancer in India. Photodiagnosis Photodyn Ther. 2022 Jun;38:102843. doi: 10.1016/j.pdpdt.2022.102843. Epub 2022 Mar 31.

  PMID: 35367616 BACKGROUND

MeSH Terms

Conditions

Mouth Neoplasms; Leukoplakia, Oral; Lichen Planus, Oral; Squamous Cell Carcinoma of Head and Neck; Carcinoma in Situ

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Leukoplakia; Precancerous Conditions; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Tayyaba Hasan, PhD

  Massachusetts General Hospital, Boston, MA, United States

  PRINCIPAL INVESTIGATOR

• Jonathan Celli, PhD

  University of Massachusetts Boston, Boston, MA, United States

  PRINCIPAL INVESTIGATOR

• Moni A Kuriakose, MD

  Karkinos Healthcare Hospitals Ernakulam, Kerala, India

  PRINCIPAL INVESTIGATOR

• Mohammad Akram, MD

  Aligarh Muslim University, Aligarh, Uttar Pradesh, India

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Celli, PhD

CONTACT

617-287-5715; jonathan.celli@umb.edu

Shakir Khan, PhD

CONTACT

781-350-0861; shakir.khan@umb.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: March 14, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will be available in compliance with publishers data availability policy, starting from the date of publication.
• Access Criteria: A data sharing agreement must first be established between the requester and the study team and their respective institutional officials. Data eligible for sharing will include any raw data that directly underlies published results (clinical reports, raw images and statistical analyses). Once a data sharing agreement is established the data can be shared using a secure link to a shared OneDrive folder or other appropriate and secure file sharing platform.

Locations

IN (2)