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Photosensitizer

PDT for Basal Cell Carcinoma

Phase 2

Recruiting

Led By Edward V Maytin, MD, PhD

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults scheduled to undergo Mohs surgery within the Dermatologic Surgery unit of the Department of Dermatology, Cleveland Clinic

Must have at least one BCC tumor eligible for removal by surgical excision

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at visit 1 (pre pdt) and visit 2 (1-14 days)

Awards & highlights

Study Summary

This trial will help researchers understand how the immune system responds to basal cell carcinoma after it's been treated with Photodynamic Therapy. This could potentially lead to new ways to fight the cancer.

Who is the study for?

This trial is for adults with at least two basal cell carcinoma (BCC) tumors that are scheduled for Mohs surgery at the Cleveland Clinic's Dermatology Department. Participants must consent to join and can be of any ethnic group. Pregnant or breastfeeding individuals, those treated for other cancers, allergic to ALA, or with a photosensitivity disease cannot participate.Check my eligibility

What is being tested?

The study aims to understand how Photodynamic Therapy (PDT) using ALA affects the immune response against BCC and could improve tumor removal when combined with other treatments. It will help develop new strategies for treating BCC by studying changes in the immune microenvironment post-PDT.See study design

What are the potential side effects?

While not explicitly listed here, common side effects of PDT may include skin redness, swelling, pain at the treatment site, and sensitivity to light. Allergic reactions to ALA might occur but participants with known hypersensitivity are excluded.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for Mohs surgery at Cleveland Clinic's Dermatology Department.

Select...

I have at least one skin cancer tumor that can be surgically removed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at visit 1 (pre pdt) and visit 2 (1-14 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at visit 1 (pre pdt) and visit 2 (1-14 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at visit 1 (pre pdt) and visit 2 (1-14 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Altered expression of immune checkpoint molecules

Altered recruitment of different immune cell subtypes in BCC tumor specimens

Time to maximum expression of immune checkpoint molecules

Secondary outcome measures

Change in the appearance of tumors

Change in the color of tumors

Change in the volume of tumors

+5 more

Side effects data

From 2010 Phase 2 trial • 107 Patients • NCT00933543

50%

Pain

48%

Erythema

26%

Pruritus

22%

Skin burning sensation

19%

Nasopharyngitis

17%

Paraestehesia

Facial pain

Skin irritation

Feeling hot

100%

80%

60%

40%

20%

Study treatment Arm

Visonac Cream With PDT

Vehicle Cream With PDT

Trial Design

1Treatment groups

Experimental Treatment

Group I: Photodynamic therapy (PDT)Experimental Treatment2 Interventions

Each participant will serve as their own control, receiving PDT for one tumor, no PDT for the second tumor (untreated control). Visit 1: Informed consent Blood draw Lesion(s) Photographed (ALA) applied for4 hours PpIX measured in lesions (PpIX buildup monitored every 30 minutes over a 4 h period) PDT with blue light Visit 2 (scheduled for within one of the following time intervals: 1-3 days, 4-7 days, or 8-14 days post-PDT): Blood draw Lesion(s) Photographed Mohs surgery After procedure, excess frozen BCC tissue will be saved for analysis

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ALA

2018

Completed Phase 2

~330

PDT

2013

Completed Phase 4

~350

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor

452 Previous Clinical Trials

31,882 Total Patients Enrolled

Edward V Maytin, MD, PhDPrincipal InvestigatorCleveland Clinic, Case Comprehensive Cancer Center

1 Previous Clinical Trials

75 Total Patients Enrolled

Media Library

ALA (Photosensitizer) Clinical Trial Eligibility Overview. Trial Name: NCT05020912 — Phase 2

Basal Cell Carcinoma Research Study Groups: Photodynamic therapy (PDT)

Basal Cell Carcinoma Clinical Trial 2023: ALA Highlights & Side Effects. Trial Name: NCT05020912 — Phase 2

ALA (Photosensitizer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05020912 — Phase 2

Frequently Asked Questions

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

What possible harms can arise from photodynamic therapy?

"PDT has been clinically tested for safety, though not efficacy. For this reason, Power's team rated it a 2 on the 1 to 3 scale."

Answered by AI

Are there other research endeavors that have explored photodynamic therapy?

"Currently, there are 18 active trials researching photodynamic therapy (PDT) with two of them in the final phase. Despite most studies being conducted in Lebanon, New hampshire, 56 total sites have PDT clinical trial availability."

Answered by AI

Are there still opportunities for individuals to join this experiment?

"According to records on clinicaltrials.gov, this medical study is actively searching for new participants; it was originally posted in November 2021 and its most recent update occurred March 2nd 2022."

Answered by AI

What is the purpose of this research endeavor?

"This trial has two distinct outcomes that need to be evaluated. Firstly, the altered expression of immunological checkpoint molecules will be monitored over 14 days after PDT using patient blood samples. Secondly, we shall compare tumor volumes and maximal PpIX levels in tumors before and after PDT treatment via 3-D imaging and dosimetric measurements respectively."

Answered by AI

How extensive is the participant base for this experiment?

"Affirmative. The clinicaltrials.gov show that this scientific experiment is currently seeking volunteers, which was initially advertised on November 9th 2021 and revised most recently on March 2nd 2022. This trial necessitates 28 individuals to be recruited from one location."

Answered by AI

What medical conditions could be treated through photodynamic therapy?

"Photodynamic Therapy (PDT) is a common treatment for scalp structure, and has also been known to be efficacious in the management of carcinoma, squamous cell carcinoma, and facial conditions."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Alteration of the Immune Microenvironment in Basal Cell Carcinoma Following Photodynamic Therapy

2021. "Alteration of the Immune Microenvironment in Basal Cell Carcinoma Following Photodynamic Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05020912.

All > Photodynamic Therapy