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

PHASE2CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

September 9, 2020

Primary Completion Date

April 4, 2025

Study Completion Date

April 4, 2025

Conditions
BCCBCC - Basal Cell CarcinomaBasal Cell CarcinomaBasal Cell CancerSuperficial Basal Cell CarcinomaNodular Basal Cell Carcinoma
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).

Trial Locations (1)

10065

Memorial Sloan Kettering Cancer Center, New York

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT04552990 - Use of Jet-injection in Photodynamic Therapy for Basal Cell Carcinoma | Biotech Hunter | Biotech Hunter