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

Phase 2

Active, not recruiting

• Conditions: Basal Cell Cancer; Superficial Basal Cell Carcinoma; BCC; BCC - Basal Cell Carcinoma; Basal Cell Carcinoma; Nodular Basal Cell Carcinoma
• Interventions: Drug: Jet injection of ALA; Procedure: Surgical excision; Other: Incubation; Procedure: Illumination

• Registration Number: NCT04552990
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-09-09
• Study First Submitted: 2020-09-10
• Study First Submitted QC: 2020-09-16
• Study First Posted: 2020-09-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03
• Primary Completion: 2025-09-09
• Study Completion: 2025-09-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 16

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tumor Excision, No Illumination	Jet injection of ALA	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.
Tumor Excision, No Illumination	Surgical excision	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.
Tumor Excision, No Illumination	Incubation	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.
PDT treatment with jet-injections	Incubation	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.
PDT treatment with jet-injections	Jet injection of ALA	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.
PDT treatment with jet-injections	Surgical excision	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.
PDT treatment with jet-injections	Illumination	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.

Primary Outcome Measures

Name	Time	Method
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 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 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 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

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States