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Photosensitizer

Photodynamic Therapy for Basal Cell Carcinoma

Phase 2
Waitlist Available
Led By Anthony Rossi, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Legally competent, able to give verbal and written informed consent
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after treatment
Awards & highlights

Study Summary

This trial is testing whether a skin cancer treatment that uses a light-activated drug is safe and has few side effects.

Who is the study for?
This trial is for adults with small, untreated basal cell carcinoma on the scalp, extremities, or trunk. Participants must be in good health, able to take photos of their skin cancer and use a smartphone app. Pregnant women, those with certain BCC subtypes or skin conditions that could affect results are excluded.Check my eligibility
What is being tested?
The study tests if using a jet-injection device to inject ALA into the skin followed by light activation is an effective treatment for basal cell carcinoma. It aims to determine safety and severity of side effects associated with this photodynamic therapy approach.See study design
What are the potential side effects?
While not specified here, potential side effects may include reactions at the injection site such as redness or swelling, pain during illumination and possible scarring given it's a treatment involving the skin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am legally able to make my own decisions and can sign consent forms.
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My skin cancer is confirmed, untreated, and less than 1 cm in size on specific body parts.
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I am 18 years old or older.
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I have superficial or nodular basal cell carcinoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months after treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical evaluation of local skin responses 3 months post treatment
Clinical evaluation of local skin responses on Day 0
Clinical evaluation of local skin responses on Day 14
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Tumor Excision, No IlluminationExperimental Treatment3 Interventions
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.
Group II: PDT treatment with jet-injectionsExperimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Surgical excision
2015
N/A
~550

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,604 Total Patients Enrolled
Anthony Rossi, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Jet injection of ALA (Photosensitizer) Clinical Trial Eligibility Overview. Trial Name: NCT04552990 — Phase 2
Basal Cell Carcinoma Research Study Groups: PDT treatment with jet-injections, Tumor Excision, No Illumination
Basal Cell Carcinoma Clinical Trial 2023: Jet injection of ALA Highlights & Side Effects. Trial Name: NCT04552990 — Phase 2
Jet injection of ALA (Photosensitizer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04552990 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are currently partaking in this research?

"Correct. According to clinicaltrials.gov, the medical study was first shared on September 9th 2020 and is actively seeking participants from 1 site. The final participant count should be 17 individuals in total."

Answered by AI

What have researchers determined about the safety of jet injection with ALA?

"After assessing the data, our team gave jet injection of ALA a score of 2. This is because it has entered its second phase and while there is evidence to suggest safety, efficacy still needs to be tested."

Answered by AI

Does this research endeavor still accept volunteers?

"Current information from clinicaltrials.gov confirms that this clinical trial is actively seeking participants, which was first posted on September 9th 2020 and last updated on February 23rd 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Use of Jet-injection in Photodynamic Therapy for Basal Cell Carcinoma
2020. "Use of Jet-injection in Photodynamic Therapy for Basal Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04552990.
All > Photodynamic Therapy
~1 spots leftby Sep 2024
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