Trial Outcomes & Findings for Low-cost Enabling Technology for Image-guided Photodynamic Therapy (PDT) of Oral Cancer Cancer. (NCT NCT03638622)

Last Updated: 2021-02-21

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Up to 2 years

Results posted on

2021-02-21

Participant Flow

Patients were evaluated at the Jawaharlal Nehru Medical College Hospital (JNMC), Aligarh, India, and at ambient remote region outpatient department (OPD) camps. Patients were enrolled if interested following exclusion and inclusion criteria.

Patients with oral lesions were screened by Ultrasound and histopathological cancer confirmation. Once a patient's oral lesion size and depth were confirmed, he/she was assigned for an oral PDT study.

Participant milestones

Participant milestones
Measure	Aminolevulinic Acid (ALA) Photodynamic Therapy (PDT) Aminolevulinic Acid (ALA) administration, Photodynamic Therapy (PDT) treatment using LED (Light-emitting diode) light source and follow-up.
Overall Study STARTED	30
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aminolevulinic Acid (ALA) Photodynamic Therapy (PDT) n=30 Participants Aminolevulinic Acid (ALA) administration, Photodynamic Therapy (PDT) treatment using LED (Light-emitting diode) light source and follow-up.
Age, Customized 21-30 years	2 years n=5 Participants
Age, Customized 31-40 years	13 years n=5 Participants
Age, Customized 41-50 years	7 years n=5 Participants
Age, Customized 51-60 years	6 years n=5 Participants
Age, Customized 61-70 years	2 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Race/Ethnicity, Customized South-Asian	30 Participants n=5 Participants
Region of Enrollment India	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 years

Outcome measures

Outcome measures
Measure	Aminolevulinic Acid (ALA) Photodynamic Therapy (PDT) n=30 Participants Aminolevulinic Acid (ALA) administration, Photodynamic Therapy (PDT) treatment using LED (Light-emitting diode) light source and follow-up.
Number of Participants With no Residual Tumor Following Photodynamic Therapy (PDT)	22 Participants

Adverse Events

Aminolevulinic Acid (ALA) Photodynamic Therapy (PDT)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Aminolevulinic Acid (ALA) Photodynamic Therapy (PDT) n=30 participants at risk Aminolevulinic Acid (ALA) administration, Photodynamic Therapy (PDT) treatment using LED (Light-emitting diode) light source and follow-up.
General disorders Discomfort during light treatment	6.7% 2/30 • Up to 2 years
General disorders Difficulty in holding PDT applicator in patient mouth	6.7% 2/30 • Up to 2 years
General disorders Hypotensive after light treatment (PDT treatment day)	3.3% 1/30 • Up to 2 years
General disorders Nausea and vomiting after light treatment	13.3% 4/30 • Up to 2 years
General disorders Mild headache after light treatment	3.3% 1/30 • Up to 2 years

Additional Information

Tayyaba Hasan

Massachusetts General Hospital, Boston

Phone: 617-726-6996

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place