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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2

Conditions: Superficial Basal Cell Carcinoma; BCC; Basal Cell Cancer; BCC - Basal Cell Carcinoma; Nodular Basal Cell Carcinoma; Basal Cell Carcinoma

Treatments: Other: Incubation; Procedure: Illumination; Drug: Jet injection of ALA; Procedure: Surgical excision

Study type: Interventional

Funder types: Other

Identifiers

NCT04552990

20-270

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Tumor Excision, No Illumination

Experimental group

Description:

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.

Treatment:

Procedure: Surgical excision

Drug: Jet injection of ALA

Other: Incubation

PDT treatment with jet-injections

Experimental group

Description:

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.

Treatment:

Procedure: Surgical excision

Drug: Jet injection of ALA

Procedure: Illumination

Other: Incubation