Clinical trial · Interventional
Photodynamic Therapy Associated With Sonodynamic Therapy for the Treatment of Nodular Basal Cell Carcinoma
Optimization of Photodynamic Therapy Through the Association With Sonodynamic Therapy for the Treatment of Nodular Basal Cell Carcinoma
NCT07381972CI-TRIAL-00102175recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Evaluation of a therapeutic protocol based on the combination of photodynamic therapy and sonodynamic therapy, referred to as sonophotodynamic therapy. Since this new protocol is applied in a single day, it is called the single-visit Sono-PDT protocol. This protocol will be used for the treatment of nodular basal cell carcinoma lesions.
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 |
|---|---|---|---|
| Nodular Basal Cell Carcinoma of Skin | Skin Nodular Basal Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control Arm (Conventional Therapy) | Combination Product | — | UNRESOLVED |
| Experimental arm | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Photodynamic therapy (PDT) protocol
- description
- In this arm, lesions will be treated with the conventional PDT protocol for this type of lesion.
- interventionNames
- Combination Product: Control Arm (Conventional Therapy)
- type
- EXPERIMENTAL
- label
- Sono-Photodynamic Therapy (SonoPDT) protocol
- description
- In this arm, lesions will be treated with a modified treatment protocol called SonoPDT protocol.
- interventionNames
- Combination Product: Experimental arm
Primary outcomes (1)
- measure
- Evaluation of the complete response rate after one month of treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDAyala ETP, Carvalho ISE, Antunes CA, Mahmood A, Requena MB, Alves F, Pires L, Yakovlev V, Bagnato VS, Pratavieira S. Comparative analysis of ALA mediated sonodynamic therapy considering tumor size, light combination and ultrasound delivery in murine cutaneous melanoma. Sci Rep. 2025 Aug 22;15(1):30859. doi: 10.1038/s41598-025-16366-x. PMID 40846765
- BACKGROUNDSalvio AG, Veneziano DB, Moriyama LT, Inada NM, Grecco C, Kurachi C, Bagnato VS. A new photodynamic therapy protocol for nodular basal cell carcinoma treatment: Effectiveness and long-term follow-up. Photodiagnosis Photodyn Ther. 2022 Mar;37:102668. doi: 10.1016/j.pdpdt.2021.102668. Epub 2021 Dec 1. PMID 34863948