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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1330-4954 | Other Identifier | UTN (Universal Trial Number) |
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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.
In the proposed treatment protocol, all the procedures of traditional PDT protocol will be maintained, with the addition of a dose of low-intensity therapeutic ultrasound immediately after the application of red light. Ultrasound, due to its greater ability to penetrate the skin, can help reach deeper tumor cells and thus improve treatment outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Photodynamic therapy (PDT) protocol | Active Comparator | In this arm, lesions will be treated with the conventional PDT protocol for this type of lesion. |
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| Sono-Photodynamic Therapy (SonoPDT) protocol | Experimental | In this arm, lesions will be treated with a modified treatment protocol called SonoPDT protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Arm (Conventional Therapy) | Combination Product | PDT protocol: This intervention consists of two therapeutic sessions performed on the same day. The first session involves the application of MAL (methyl aminolevulinate) cream to the skin tumor, followed by an incubation period of 3 hours. After this time, the lesion is illuminated for 20 minutes at an irradiance of 125 mW/cm² using the LINCE device. Following the illumination procedure, the second session begins with a new application of MAL cream and an additional 1.5 hours of incubation. After this period, illumination is performed using the same light parameters as in the first session. After each MAL application, an occlusive dressing composed of PVC film, aluminum foil, gauze, and adhesive tape is applied to the lesion area to prevent light exposure and degradation of the produced PpIX. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the complete response rate after one month of treatment. | Complete response will be defined as the absence of clinical and/or histopathological signs of the tumor after one month of treatment. | One month after the treatment was applied to the patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the complete response rate and recurrence-free survival rate after six months of treatment. | Complete response will be defined as the absence of clinical and/or histopathological evidence of the tumor. Recurrence-free survival at 6 months will be determined by the proportion of patients who show no recurrence of the lesion at the treated site or in adjacent areas within 6 months, relative to the total number of patients treated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana G Salvio, Doctor | Contact | +55 (14) 3602-1374 | gasalvio@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Amaral Carvalho | Recruiting | Jaú | São Paulo | 17210-080 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40846765 | Background | Ayala 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. | |
| 34863948 |
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| Experimental arm | Combination Product | SonoPDT protocol: This intervention consists of two therapeutic sessions performed on the same day. The first session involves the application of MAL (methyl aminolevulinate) cream to the skin tumor, followed by an incubation period of 3 hours. After this time, the lesion is illuminated for 20 minutes at an irradiance of 125 mW/cm² using the LINCE device. Immediately after illumination, the lesion will be irradiated with ultrasound (frequency: 1MHz, mode: pulsed, ultrasound intensity: 1.5 W/cm2, duty cycle: 50%, pulse frequency: 100 Hz) for 5 minutes. Following the sonication procedure, the second session begins with a new application of MAL cream with an incubation period of 1.5 hours. After this time, illumination and sonication are performed using the same excitation source parameters as in the first session. |
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| Six months after the treatment was applied to the patient. |
| Salvio 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. |