Clinical Trials /

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

NCT04552990

Description:

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.

Related Conditions:
  • Skin Nodular Basal Cell Carcinoma
  • Superficial Basal Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Use of Jet-injection in Photodynamic Therapy for Basal Cell Carcinoma
  • Official Title: Jet-Injection Assisted Photodynamic Therapy for Basal Cell Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: 20-270
  • NCT ID: NCT04552990

Conditions

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

Interventions

DrugSynonymsArms
Jet injection of ALAPDT treatment with jet-injections

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Tumor Excision, No IlluminationExperimentalThe 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.
  • Jet injection of ALA
PDT treatment with jet-injectionsExperimentalPatient 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.
  • Jet injection of ALA

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 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.

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Clinical evaluation of local skin responses on Day 0
Time Frame:Day 1
Safety Issue:
Description:Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 0 (PDT treatment #1)

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial 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

Last Updated

September 16, 2020