- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04552990
Use of Jet-injection in Photodynamic Therapy for Basal Cell Carcinoma
May 4, 2023 updated by: Memorial Sloan Kettering Cancer Center
Jet-Injection Assisted Photodynamic Therapy for Basal Cell Carcinoma
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Anthony Rossi, MD
- Phone Number: 646-608-2311
- Email: rossia@mskcc.org
Study Contact Backup
- Name: Allan Halpern, MD
- Phone Number: 646-608-2328
- Email: halperna@mskcc.org
Study Locations
-
-
New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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).
In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted).
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.
|
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).
In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted).
After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min).
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Day 1
|
Clinical evaluation of local skin responses on Day 3
Time Frame: Day 3
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Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 3
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Day 3
|
Clinical evaluation of local skin responses on Day 14
Time Frame: Day 14
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Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 14 (PDT treatment #2)
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Day 14
|
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
|
Day 17
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Clinical evaluation of local skin responses 3 months post treatment
Time Frame: 3 months after treatment
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Clinical evaluation of local skin responses on a 0-4 point scale will be performed 3 months post treatment
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3 months after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Anthony Rossi, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 9, 2020
Primary Completion (Anticipated)
September 9, 2024
Study Completion (Anticipated)
September 9, 2024
Study Registration Dates
First Submitted
September 10, 2020
First Submitted That Met QC Criteria
September 16, 2020
First Posted (Actual)
September 17, 2020
Study Record Updates
Last Update Posted (Estimate)
May 5, 2023
Last Update Submitted That Met QC Criteria
May 4, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-270
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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