Understanding Immune Response to Photodynamic Therapy for Basal Cell Carcinoma

This study aims to understand how your body's immune system responds to basal cell carcinoma (BCC) when treated with Photodynamic Therapy (PDT). PDT uses a special drug called ALA applied to the skin and then activated by blue light to kill cancer cells. Researchers want to see if PDT changes certain immune cells and molecules in BCC tumors, which could help develop better treatments in the future. You might be able to join if you are an adult (over 18) with at least one BCC tumor scheduled for surgical removal at Cleveland Clinic. The study will look for changes in immune cells and molecules in your tumor within 1-14 days after PDT. The study's current status is unclear, and it plans to enroll 18 participants.

Study design
This is an interventional study with 18 planned participants. It's an internally controlled trial where one tumor will receive PDT and another will be an untreated control.
What's involved
You would have ALA applied to one BCC lesion, followed by PDT with blue light for 30 minutes. Tissue samples will be taken at a second visit within 1-14 days.
Compensation
Not stated in the trial record.
Follow-up
Your immune response will be measured within 1-14 days after PDT treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05020912

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

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
Case Comprehensive Cancer Center
~18 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:ALAPDT

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to maximum expression of immune checkpoint molecules
Measured over at visit 2 (1-14 days)
+2 more outcomes measured
Basal Cell Carcinoma
1 sites across 1 states
Ohio1
  • Edward V Maytin, MD, PhD · PRINCIPAL_INVESTIGATOR · Cleveland Clinic, Case Comprehensive Cancer Center

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Must be an adult parcticpant (\> 18 yrs) who is scheduled to undergo BCC surgery (via Mohs surgery, ED\&C, or standard elliptical excision) within the Dermatologic Surgery unit of the Department of Dermatology, Cleveland Clinic.
Must have at least one BCC tumor eligible for surgical removal
Participants of any ethnic group are eligible for this trial.
Must provide informed consent to participate in the trial.

Exclusion

Pregnant or breastfeeding
Currently being treated for other cancers with medical or radiation therapy
Known hypersensitivity to 5-aminolevulinic acid
History of a photosensitivity disease, e.g., porphyria cutanea tarda
  • Time to maximum expression of immune checkpoint moleculesat visit 2 (1-14 days)

    Time (days) to maximum expression of immune checkpoint molecules in BCC tumors and peri-tumoral stroma after PDT, as compared to untreated tumors. Data from frozen BCC specimens post-PDT by immunostaining the tumor specimens with antibodies against PD-L1, PD-1, CTLA-4 as well as the newer IC molecules TIGIT, TIM-3, and LAG-3

  • Altered expression of immune checkpoint moleculesat visit 2 (1-14 days)

    Altered expression of immune checkpoint molecules in BCC tumor specimens after PDT. Assessed by comparing IC molecule expression in PDT treated and untreated tumors with immunostaining in the tumor specimens with antibodies against PD-L1, PD-1, CTLA-4 as well as the newer IC molecules TIGIT, TIM-3, and LAG-3. (quantifying with immunofluorescence microscope)

  • Altered recruitment of different immune cell subtypes in BCC tumor specimensat visit 2 (1-14 days)

    Determine the ratio of cytotoxic T cells to regulatory T cells in BCC tumors and peri-tumoral stroma after PDT, as compared to untreated tumors. Measured with specific antibodies against the following markers, to determine the qualitative time course of infiltration by each immune cell populations: Neutrophils (Gr1+ or MPO+); Macrophages(F4/80+); MDSCs (CD33, S100A9); cytotoxicT-cells(CD8+); regulatory T-cells(CD4+,FoxP3+,CD25+, CD127-); NK natural killer cells(CD56+CD16+).