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

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ClinicalTrials.gov Identifier: NCT04552990
Recruitment Status : Recruiting
First Posted : September 17, 2020
Last Update Posted : April 15, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
BCC BCC - Basal Cell Carcinoma Basal Cell Carcinoma Basal Cell Cancer Superficial Basal Cell Carcinoma Nodular Basal Cell Carcinoma Drug: Jet injection of ALA Procedure: Surgical excision Procedure: Illumination Other: Incubation Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 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 : September 9, 2020
Estimated Primary Completion Date : September 9, 2022
Estimated Study Completion Date : September 9, 2022

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).




Primary Outcome Measures :
  1. Clinical evaluation of local skin responses on Day 0 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3 months after treatment ]
    Clinical evaluation of local skin responses on a 0-4 point scale will be performed 3 months post treatment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 or nodular BCCs < 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 (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

Exclusion Criteria:

Subjects meeting any one of the following criteria are not eligible to participate in this study

  • High-risk BCC (H area, >1 cm in M area, or >2 cm in L area)
  • BCC 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04552990


Contacts
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Contact: Anthony Rossi, MD 646-608-2311 rossia@mskcc.org
Contact: Allan Halpern, MD 646-608-2328 halperna@mskcc.org

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Anthony Rossi, MD    646-608-2311      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Anthony Rossi, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04552990    
Other Study ID Numbers: 20-270
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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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:
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
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Basal Cell
Neoplasms, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms