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

Study Overview
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Brief Summary
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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
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Jet-Injection Assisted Photodynamic Therapy for Basal Cell Carcinoma

Conditions
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BCC, BCC - Basal Cell Carcinoma, Basal Cell Carcinoma, Basal Cell Cancer, Superficial Basal Cell Carcinoma, Nodular Basal Cell Carcinoma

Intervention / Treatment
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* Drug: Jet injection of ALA
* Procedure: Surgical excision
* Procedure: Illumination
* Other: Incubation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who meet all of the following criteria are eligible to participate in this study Histologically-verified, previously untreated low-risk mixed superficial and nodular BCC(s) or nodular BCC(s) < 1 cm in diameter on scalp, extremities, or trunk. ≥ 18 years of age Owner of a smartphone (Android or iPhone). Patients without a working smartphone will not be considered eligible for this study. Being able to download application on their phone Being able to take pictures of their treated BCC(s) (with or without assistance) Female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment. (Female subjects are considered of childbearing potential unless they have been hysterectomized or have undergone tubal ligation or have been post-menopausal for at least one year prior to the first visit) Legally competent, able to give verbal and written informed consent Subject in good general health and willing to participate comply with protocol requirements. Superficial and nodular BCC(s) Exclusion Criteria: Subjects meeting any one of the following criteria are not eligible to participate in this study High-risk BCC(s) (H area, >1 cm in M area, or >2 cm in L area) BCC(s) subtype morpheaform Diagnosed with gorlin syndrome Receiving immunosuppressive medication Subjects with a known allergy to ALA Individuals with other interfering skin diseases in the area of treatment Subjects with a tattoo in the treatment area which may interfere with or confound the evaluation of the study Subjects with a history of keloids which is deemed clinically relevant in the opinion of the investigator Lactating or pregnant women Patient who are taking prescription pain medications or can not stop OTC pain medications.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tumor Excision, No Illumination<br>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. | Drug: Jet injection of ALA<br>* 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).<br>Procedure: Surgical excision<br>* In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted).<br>Other: Incubation<br>* After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min).<br>|
| Experimental: PDT treatment with jet-injections<br>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. | Drug: Jet injection of ALA<br>* 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).<br>Procedure: Surgical excision<br>* In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted).<br>Procedure: Illumination<br>* 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).<br>Other: Incubation<br>* After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evaluation of local skin responses on Day 0 | Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 0 (PDT treatment #1) | Day 1 | 
| Clinical evaluation of local skin responses on Day 3 | Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 3 | Day 3 | 
| Clinical evaluation of local skin responses on Day 14 | Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 14 (PDT treatment #2) | Day 14 | 
| Clinical evaluation of local skin responses on Day 17 | Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 17 | Day 17 | 
| Clinical evaluation of local skin responses 3 months post treatment | Clinical evaluation of local skin responses on a 0-4 point scale will be performed 3 months post treatment | 3 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Superficial BBC, Nodular BBC, Superficial Basal Cell Carcinoma, Nodular Basal Cell Carcinoma, BCC, Basal Cell Carcinoma, PDT treatment, photodynamic therapy, Jet injection, Memorial Sloan Kettering Cancer Center, 20-270