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

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04552990
Collaborator
(none)
17
1
2
36
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Jet injection of ALA
  • Procedure: Surgical excision
  • Procedure: Illumination
  • Other: Incubation
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
17 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Jet-Injection Assisted Photodynamic Therapy for Basal Cell Carcinoma
Actual Study Start Date :
Sep 9, 2020
Anticipated Primary Completion Date :
Sep 9, 2023
Anticipated Study Completion Date :
Sep 9, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tumor Excision, No Illumination

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
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).

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

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

Experimental: PDT treatment with jet-injections

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
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).

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

Procedure: Illumination
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).

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

Outcome Measures

Primary Outcome Measures

  1. 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)

  2. 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

  3. 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)

  4. 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

  5. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Memorial Sloan Kettering Cancer Center New York New York United States 10065

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Anthony Rossi, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT04552990
Other Study ID Numbers:
  • 20-270
First Posted:
Sep 17, 2020
Last Update Posted:
Feb 24, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 24, 2022