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
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|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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Subjects with histopathological confirmation of newly diagnosed (Cohort A) or locally recurrent (Cohort B) malignant cutaneous lesions of the following histopathologies:
- Lentigo maligna melanoma (Dubreuilh melanoma)
Acceptable tumor locations include the following:
- Skin (facial, scalp, extremities, torso)
- Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
- Target lesion technically amenable for full tumor coverage with the Alpha DaRT seeds.
- Measurable disease according to RECIST v1.1.
- Subjects over 18 years old.
- Subjects' ECOG Performance Status Scale is < 2.
- Subjects' life expectancy is more than 6 months.
- Platelet count ≥100,000/mm3.
- International normalized ratio of prothrombin time ≤1.8.
- Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.
- Subjects are willing to sign an informed consent form
Subject has a tumor with histology of one of the following:
- Merkel cell carcinoma
- Sarcoma other than carcinosarcoma
- Metastatic disease (according to the TNM staging system - M1 patients are excluded)
- Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.).
- Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
- Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.
- High probability of protocol non-compliance (in opinion of investigator).
- Subjects not willing to sign an informed consent.
- Women who are pregnant or breastfeeding.
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|
|CHU Grenoble Alpes||Recruiting|
|Grenoble, France, 38700|
|Contact: M. Camille Verry, MD 33 (0) 476765435 email@example.com|
|Centre Léon Bérard||Recruiting|
|Lyon, France, 69008|
|Contact: POMMIER Pascal, MD 33 (0) 478785166 firstname.lastname@example.org|
|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|
|Responsible Party:||Alpha Tau Medical LTD.|
|Other Study ID Numbers:||
|First Posted:||August 28, 2019 Key Record Dates|
|Last Update Posted:||January 18, 2023|
|Last Verified:||April 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Squamous Cell Carcinoma
Basal Cell Carcinoma
Lentigo maligna melanoma
Neoplasms by Site