Last reviewed · How we verify

NCT03638622: UH3-India

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

Completed Phase 1, PHASE2 Results posted Last updated 21 February 2021
What this trial tests

Phase 1, PHASE2 trial testing Photodynamic Therapy in Oral Cancer in 30 participants. Completed in 12 October 2020.

Timeline
10 March 2017
Primary endpoint
12 October 2020
12 October 2020

Quick facts

Lead sponsorMassachusetts General Hospital
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date10 March 2017
Primary completion12 October 2020
Estimated completion12 October 2020
Sites1 location across India

Drugs / interventions tested

Conditions studied

Sponsor

Massachusetts General Hospital

Who can join

21 and older, any sex, with Oral Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With no Residual Tumor Following Photodynamic Therapy (PDT) Primary · 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).

GroupValue95% CI
Aminolevulinic Acid (ALA) Photodynamic Therapy (PDT)22

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 2 years. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Aminolevulinic Acid (ALA) Photodynamic Therapy (PDT)
Serious: 0/30 (0%)
Deaths: 0/30
Other adverse events (5 terms — click to expand)

ReactionSystemAminolevulinic Acid (ALA) …
Nausea and vomiting after light treatmentGeneral disorders
Discomfort during light treatmentGeneral disorders
Difficulty in holding PDT applicator in patient mouthGeneral disorders
Hypotensive after light treatment (PDT treatment day)General disorders
Mild headache after light treatmentGeneral disorders

Data from ClinicalTrials.gov NCT03638622 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Immunomodulation of the Tumor Microenvironment: Turn Foe Into Friend.
    Locy H, de Mey S, de Mey W, De Ridder M, et al · · 2018 · cited 183× · PMID 30619273 · DOI 10.3389/fimmu.2018.02909
  2. Drug-induced oxidative stress in cancer treatments: Angel or devil?
    Jiang H, Zuo J, Li B, Chen R, et al · · 2023 · cited 130× · PMID 37224697 · DOI 10.1016/j.redox.2023.102754
  3. Engineering photodynamics for treatment, priming and imaging.
    Obaid G, Celli JP, Broekgaarden M, Bulin AL, et al · · 2024 · cited 88× · PMID 39927170 · DOI 10.1038/s44222-024-00196-z
  4. Combinatorial Therapeutic Approaches with Nanomaterial-Based Photodynamic Cancer Therapy.
    Hao Y, Chung CK, Yu Z, Huis In 't Veld RV, et al · · 2022 · cited 38× · PMID 35057015 · DOI 10.3390/pharmaceutics14010120
  5. Trial watch: an update of clinical advances in photodynamic therapy and its immunoadjuvant properties for cancer treatment.
    Penetra M, Arnaut LG, Gomes-da-Silva LC. · · 2023 · cited 36× · PMID 37346450 · DOI 10.1080/2162402x.2023.2226535
  6. Clinical evaluation of a mobile, low-cost system for fluorescence guided photodynamic therapy of early oral cancer in India.
    Siddiqui SA, Siddiqui S, Hussain MAB, Khan S, et al · · 2022 · cited 23× · PMID 35367616 · DOI 10.1016/j.pdpdt.2022.102843
  7. Biocompatible Nanocarriers for Enhanced Cancer Photodynamic Therapy Applications.
    Dhilip Kumar SS, Abrahamse H. · · 2021 · cited 21× · PMID 34834348 · DOI 10.3390/pharmaceutics13111933
  8. Towards Photodynamic Image-Guided Surgery of Head and Neck Tumors: Photodynamic Priming Improves Delivery and Diagnostic Accuracy of Cetuximab-IRDye800CW.
    Bhandari C, Fakhry J, Eroy M, Song JJ, et al · · 2022 · cited 13× · PMID 35837101 · DOI 10.3389/fonc.2022.853660

Verify or expand the search:

Other trials of Photodynamic Therapy

Trials testing the same drug.

Other recruiting trials for Oral Cancer

Currently open trials in the same condition.

Other Massachusetts General Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03638622.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing