NCT04552990

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

Jet-Injection Assisted Photodynamic Therapy for Basal Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• BCC
• BCC - Basal Cell Carcinoma
• Basal Cell Carcinoma
• Basal Cell Cancer
• Superficial Basal Cell Carcinoma
• Nodular Basal Cell Carcinoma

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2020-09-09
• Primary completion: 2025-04-04
• Completion: 2025-04-04
• First posted: 2020-09-17
• Last updated: 2025-04-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study