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COMPLETED
NCT04552990
PHASE2

Use of Jet-injection in Photodynamic Therapy for Basal Cell Carcinoma

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to find out whether injecting ALA into the skin with a jet-injection device and activating the drug with light is a safe treatment that causes few or mild side effects in people with basal cell carcinoma.

Official title: Jet-Injection Assisted Photodynamic Therapy for Basal Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2020-09-09

Completion Date

2025-04-04

Last Updated

2026-06-18

Healthy Volunteers

No

Interventions

DRUG

Jet injection of ALA

The Basal Cell Carcinoma/BCC tumor and a 5 mm margin will be injected with a grid of 80 microliters of 20% ALA at 5-8.5 mm between each injection (30-50% overlap).

PROCEDURE

Surgical excision

In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted).

PROCEDURE

Illumination

For patients 5-16,after 3h incubation (+/- 30 min), the tumor will be illuminated with red light corresponding to a dose of 75 J/cm2 570- 670 nm or equivalent dose of narrowband red light. The intervention will be repeated at after 14 days in patient 5-16. If the wound is not healed at two weeks, the treatment may be postponed to allow healing (patient 5-16).

OTHER

Incubation

After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min).

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States