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

NCT04552990 | Completed Phase 2 FDA Drug

• 1 other identifier: 20-270
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Superficial BBC; Nodular BBC; Superficial Basal Cell Carcinoma; Nodular Basal Cell Carcinoma; BCC; Basal Cell Carcinoma; PDT treatment; photodynamic therapy; Jet injection; Memorial Sloan Kettering Cancer Center; 20-270

Outcome Measures

Primary Outcomes (5)

• Clinical evaluation of local skin responses on Day 0

  Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 0 (PDT treatment #1)

  Day 1

• Clinical evaluation of local skin responses on Day 3

  Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 3

  Day 3

• Clinical evaluation of local skin responses on Day 14

  Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 14 (PDT treatment #2)

  Day 14

• Clinical evaluation of local skin responses on Day 17

  Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 17

  Day 17

• Clinical evaluation of local skin responses 3 months post treatment

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

  3 months after treatment

Study Arms (2)

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.

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

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.

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

Interventions

Jet injection of ALA DRUG

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).

PDT treatment with jet-injections; Tumor Excision, No Illumination

Surgical excision PROCEDURE

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

PDT treatment with jet-injections; Tumor Excision, No Illumination

Illumination PROCEDURE

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).

PDT treatment with jet-injections

Incubation OTHER

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

PDT treatment with jet-injections; Tumor Excision, No Illumination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Carcinoma, Basal Cell; Neoplasms, Basal Cell

Interventions

Lighting; Infectious Disease Incubation Period

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Environment, Controlled; Environment; Environment and Public Health; Disease Transmission, Infectious; Public Health

Study Officials

• Anthony Rossi, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 17, 2020
• Study Start: September 9, 2020
• Primary Completion: April 4, 2025
• Study Completion: April 4, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)