Alpha Radiation Emitters Device for the Treatment of of Malignant Cutaneous Tumors
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|ClinicalTrials.gov Identifier: NCT04068155|
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : January 18, 2023
|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|
|Actual Study Start Date :||April 1, 2022|
|Estimated Primary Completion Date :||January 2024|
|Estimated Study Completion Date :||January 2024|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068155
|Contact: Liron Dimnik||+972-2-373-7000||LironD@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:||Dr Camille VERRY||University Hospital, Grenoble|