At a glance
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Jet-Injection Assisted Photodynamic Therapy for Basal Cell Carcinoma
In Brief
A Phase 2 clinical trial evaluating Jet injection of ALA, Surgical excision, and 2 other interventions for BCC and 5 related conditions. Completed, enrolled 16 participants across 1 site.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
The first four patients will not receive illumination but have their tumors excised after jet-injection (AirGent2.0) of ALA (Levulan Kerastick), and 3h incubation; this will be done to assess biodistribution of ALA through fluorescence microscopy.
Patient 5-16 will receive PDT treatment with jet-injections of ALA followed by 3h incubation under occlusion and thereafter illumination with red light (total dose 75 J/cm2). In patient 5-16, the PDT treatment will be repeated after 2 weeks.
Interventions
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).
In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted).
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).
After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min).