Clinical trial · Interventional
Alteration of the Immune Microenvironment in Basal Cell Carcinoma Following Photodynamic Therapy
Alteration of the Immune Microenvironment in Basal Cell Carcinoma (BCC) Following Photodynamic Therapy (PDT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to better understand the immune response to basal cell carcinoma (BCC) treated with Photodynamic Therapy (PDT) in order to develop new methods of treating BCC. Previous research suggests that PDT alters the immune response, possibly in a way that could promote better tumor clearance when combined with other treatments. Overall, participation in this study will help the study team better understand the anti-tumor immune response when BCC is treated with PDT.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ALA | Drug | — | UNRESOLVED |
| PDT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Photodynamic therapy (PDT)
- description
- 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
- interventionNames
- Drug: ALA
- Procedure: PDT
Primary outcomes (3)
- measure
- Time to maximum expression of immune checkpoint molecules
- timeFrame
- at visit 2 (1-14 days)
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * 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 Criteria * 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
References
Publications (0)
Data not yet available