Photodynamic Therapy Associated With Sonodynamic Therapy for the Treatment of Nodular Basal Cell Carcinoma
Recruiting · NCT07381972 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Sao Paulo
View the official record on ClinicalTrials.gov →Interventions studied
Control Arm (Conventional Therapy)Experimental arm
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Hospital Amaral Carvalho - Jaú, São Paulo, Brazil