Alpha Radiation Emitters Device for the Treatment of of Malignant Cutaneous Tumors
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|ClinicalTrials.gov Identifier: NCT04068155|
Recruitment Status : Not yet recruiting
First Posted : August 28, 2019
Last Update Posted : July 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Skin Cancer Cutaneous Tumor Cutaneous Metastasis||Device: DaRT- Diffusing Alpha-emitters Radiation Therapy||Not Applicable|
This will be a prospective, open label, single arm, multi- center study, assessing the safety and effectiveness of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor.
This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients.
Cutaneous lesions with histopathological confirmation of malignancy will be treated using DaRT seeds.
Reduction in tumor size 9-11 weeks following DaRT insertion will be assessed. Safety will be assessed by the frequency, severity and causality of all Adverse Events (AE).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous Tumors|
|Estimated Study Start Date :||October 2020|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||January 2023|
Experimental: DaRT Seeds Intratumoral Diffusing alpha-emitters
An intratumoral insertion of securely fixed seeds loaded with Radium-224. The seeds release by recoil short-lived alpha-emitting atoms into the tumor.
Device: DaRT- Diffusing Alpha-emitters Radiation Therapy
Seed(s) loaded with Radium-224 for local intratumoral irradiation with the destructive power of alpha particles
- The objective response rate to DaRT treatment [ Time Frame: up to 9-11 weeks ]Assessment of tumor response rate using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
- Tumor volume [ Time Frame: up to 9-11 weeks ]Assessment of the reduction in tumor volume based on imaging tests
- DaRT seeds placement [ Time Frame: Day of DaRT insertion procedure ]Assessment of the DaRT seed placement by localization of the DaRT seed in the tumor using CT imaging
- Change in quality of life as assessed by the Skindex-16 questionnaire [ Time Frame: up to 9-11 weeks ]Assessment of patient reported health-related Quality of Life (QoL) outcomes using the Skindex-16 questionnaire
- Disease-Free Survival (DFS) rate [ Time Frame: up to 24 months ]Assessment of Disease-Free Survival
- Change in quality of life as assessed by the Skin Cancer Index (SCI) questionnaire [ Time Frame: up to 9-11 weeks ]Assessment of patient reported health-related Quality of Life (QoL) outcomes using the Skin Cancer Index (SCI) questionnaire.
- Adverse Events [ Time Frame: up to 24 months ]Assessment of the frequency, severity and causality of adverse events related and not related to the DaRT treatment. Adverse events will be assessed and graded according to Common Terminology and Criteria for adverse events (CTCAE) version 5.0.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068155
|Contact: Naama Barel||+972-3-618-24770||Naamab@alphatau.com|
|Contact: Amnon Gat||Amnong@alphatau.com|
|Principal Investigator:||Dr Pascal POMMIER||Centre Leon Berard|
|Principal Investigator:||Pr Jean Michel HANNOUN LEVI||Antoine Lacassagne Cancer Center|
|Principal Investigator:||Pr Jean Marc COSSET||Amethyst (Garenne-Colombes)|
|Principal Investigator:||Dr Pierre BLANCHARD||Gustave Roussy, Cancer Campus, Grand Paris|
|Principal Investigator:||Dr Anne DUCASSOU||Institut Universitaire du Cancer Toulouse - Oncopole|
|Principal Investigator:||Dr Sophie RENARD||Institut de Cancérologie de Lorraine, Nancy|
|Principal Investigator:||Dr Camille VERRY||University Hospital, Grenoble|
|Principal Investigator:||Dr Alain TOLEDANO||Institut de Cancérologie Hartmann|