Neoplasms

All Conditions

Carcinoma

Carcinoma, Basal Cell

Neoplasms, Basal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Dermatologic Agents

All Drugs and Chemicals

Aminolevulinic Acid

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.

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).

Jet injection of ALA

In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted).

Surgical excision

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).

Illumination

After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min).

Incubation

Anthony Rossi, MD

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.

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

Jet-Injection Assisted Photodynamic Therapy for Basal Cell Carcinoma

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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 a 0-4 point scale will be performed at Day 3

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 a 0-4 point scale will be performed at Day 17

Clinical evaluation of local skin responses on a 0-4 point scale will be performed 3 months post treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Use of Jet-injection in Photodynamic Therapy for Basal Cell Carcinoma	NCT04552990	BCC BCC - Basal Cel... Basal Cell Carc... Basal Cell Canc... Superficial Bas... Nodular Basal C...	Jet injection o... Surgical excisi... Illumination Incubation	18 Years -	Memorial Sloan Kettering Cancer Center
Use of Jet-injection in Photodynamic Therapy for Basal Cell Carcinoma	NCT04552990	BCC BCC - Basal Cel... Basal Cell Carc... Basal Cell Canc... Superficial Bas... Nodular Basal C...	Jet injection o... Surgical excisi... Illumination Incubation	18 Years -	Memorial Sloan Kettering Cancer Center

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