Single‑visit light plus ultrasound treatment for small nodular basal cell carcinoma
Official title: Optimization of Photodynamic Therapy Through the Association With Sonodynamic Therapy for the Treatment of Nodular Basal Cell Carcinoma
Run by University of Sao Paulo · NCT07381972 · Data updated 2026-11-12
This trial will test a single‑visit combination of photodynamic therapy with low‑intensity ultrasound (sono‑PDT) to treat adults who have small nodular basal cell carcinoma lesions.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 142 (estimated) |
| Sponsor | University of Sao Paulo Academic / other |
| Locations | 1 site (Jaú, São Paulo) |
| Status | Recruiting |
| Started | November 24, 2025 |
| Main results expected | August 2026 |
| Study ends | December 2026 |
| Registry record updated | February 2, 2026 |
| Trial ID | NCT07381972 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with histologically confirmed nodular basal cell carcinoma lesions 1.0 cm or smaller (including multiple lesions if each meets criteria) are ideal candidates.
✕Probably not a fit
Patients with lesions larger than 1.0 cm, infiltrative or morpheaform histologic subtypes, porphyria or photosensitivity disorders, allergy to the photosensitizer, or pregnant/breastfeeding women are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3 trial compares the standard photodynamic therapy protocol with a single‑visit sono‑PDT protocol that adds low‑intensity therapeutic ultrasound immediately after red‑light application to reach deeper tumor cells. The study keeps all conventional PDT procedures and adds one ultrasound dose on the same day to potentially enhance penetration and tumor kill. Eligible lesions are nodular basal cell carcinomas up to 1.0 cm in diameter, and participants with multiple eligible lesions may be treated. Treatments are delivered at a single study site and outcomes will compare the experimental combination against conventional therapy.
Why it matters
Potential benefit: If successful, the combined sono‑PDT approach could improve clearance of deeper tumor cells while offering a convenient single‑visit, non‑surgical treatment option for small nodular BCCs.
How similar studies have gone: Topical PDT alone has established efficacy for superficial and some small nodular BCCs, but adding sonodynamic therapy is a relatively novel approach with limited clinical data to date.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults of both sexes, aged 18 years and older. * Histologically confirmed nodular basal cell carcinoma with lesion diameter ≤1.0 cm. * Participants with multiple lesions may be included, provided that each lesion meets all inclusion criteria. Exclusion Criteria: * Nodular basal cell carcinoma lesions \>1.0 cm in diameter. * Known hypersensitivity or allergy to methyl aminolevulinate (MAL) or any excipients of the study medication. * Histological subtypes of infiltrative basal cell carcinoma, including micronodular, infiltrative, sclerodermiform (morpheaform), plano-cicatricial, or terebrant subtypes. * Porphyria or other disorders of porphyrin metabolism. * Pregnant or breastfeeding women. * Women of childbearing potential not using an acceptable method of contraception. * Presence of photosensitive diseases, including lupus erythematosus. * Any condition that, in the investigator's opinion, would interfere with study participation or safety.
Where it's running
-
Hospital Amaral Carvalho
Jaú, São Paulo, Brazil Recruiting
Study contacts
- Study coordinator: Ana G Salvio, Doctor
- Email: gasalvio@hotmail.com
- Phone: +55 (14) 3602-1374
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.