Use of Jet-injection in Photodynamic Therapy for Basal Cell Carcinoma
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Tumor Excision, No Illumination 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
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).
Other: Incubation
After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min).
|
Experimental: PDT treatment with jet-injections 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
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).
|
Outcome Measures
Primary Outcome Measures
- Clinical evaluation of local skin responses on Day 0 [Day 1]
Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 0 (PDT treatment #1)
- Clinical evaluation of local skin responses on Day 3 [Day 3]
Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 3
- Clinical evaluation of local skin responses on Day 14 [Day 14]
Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 14 (PDT treatment #2)
- Clinical evaluation of local skin responses on Day 17 [Day 17]
Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 17
- Clinical evaluation of local skin responses 3 months post treatment [3 months after treatment]
Clinical evaluation of local skin responses on a 0-4 point scale will be performed 3 months post treatment
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
Sponsors and Collaborators
- Memorial Sloan Kettering Cancer Center
Investigators
- Principal Investigator: Anthony Rossi, MD, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 20-270