Alteration of the Immune Microenvironment in Basal Cell Carcinoma (BCC) Following Photodynamic Therapy (PDT)

Who is this study for? Patients with Basal Cell Carcinoma
What treatments are being studied? ALA+Photodynamic Therapy
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Men and women of any ethnic group are eligible

• Must provide informed consent to participate

Locations
United States
Ohio
Cleveland Clinic, Case Comprehensive Cancer Center
RECRUITING
Cleveland
Contact Information
Primary
Edward V Maytin, MD, PhD
maytine@ccf.org
216-444-5139
Time Frame
Start Date: 2021-12-13
Estimated Completion Date: 2027-12
Participants
Target number of participants: 28
Treatments
Experimental: Photodynamic therapy (PDT)
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
Related Therapeutic Areas
Basal Cell Skin Cancer
Sponsors
Leads: Case Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov

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