Description:
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.
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.
Recruiting
Phase 2
Drug | Synonyms | Arms |
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Jet injection of ALA | PDT treatment with jet-injections |
Name | Type | Description | Interventions |
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Tumor Excision, No Illumination | Experimental | 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. |
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PDT treatment with jet-injections | Experimental | 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. |
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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 or nodular BCCs < 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 (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 Exclusion Criteria: Subjects meeting any one of the following criteria are not eligible to participate in this study - High-risk BCC (H area, >1 cm in M area, or >2 cm in L area) - BCC 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Clinical evaluation of local skin responses on Day 0 |
Time Frame: | Day 1 |
Safety Issue: | |
Description: | Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 0 (PDT treatment #1) |
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Memorial Sloan Kettering Cancer Center |
April 15, 2021