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

Primary Purpose

BCC, BCC - Basal Cell Carcinoma, Basal Cell Carcinoma

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Jet injection of ALA
Surgical excision
Illumination
Incubation
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for BCC focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Tumor Excision, No Illumination

PDT treatment with jet-injections

Arm 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.

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.

Outcomes

Primary Outcome Measures

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)
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
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)
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
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

Secondary Outcome Measures

Full Information

First Posted
September 10, 2020
Last Updated
May 4, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04552990
Brief Title
Use of Jet-injection in Photodynamic Therapy for Basal Cell Carcinoma
Official Title
Jet-Injection Assisted Photodynamic Therapy for Basal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 9, 2020 (Actual)
Primary Completion Date
September 9, 2024 (Anticipated)
Study Completion Date
September 9, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tumor Excision, No Illumination
Arm Type
Experimental
Arm 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.
Arm Title
PDT treatment with jet-injections
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Jet injection of ALA
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Surgical excision
Intervention Description
In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted).
Intervention Type
Procedure
Intervention Name(s)
Illumination
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Incubation
Intervention Description
After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min).
Primary Outcome Measure Information:
Title
Clinical evaluation of local skin responses on Day 0
Description
Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 0 (PDT treatment #1)
Time Frame
Day 1
Title
Clinical evaluation of local skin responses on Day 3
Description
Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 3
Time Frame
Day 3
Title
Clinical evaluation of local skin responses on Day 14
Description
Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 14 (PDT treatment #2)
Time Frame
Day 14
Title
Clinical evaluation of local skin responses on Day 17
Description
Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 17
Time Frame
Day 17
Title
Clinical evaluation of local skin responses 3 months post treatment
Description
Clinical evaluation of local skin responses on a 0-4 point scale will be performed 3 months post treatment
Time Frame
3 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Rossi, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

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

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