Alpha Radiation Emitters Device for the Treatment of of Malignant Cutaneous Tumors
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| ClinicalTrials.gov Identifier: NCT04068155 |
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Recruitment Status :
Recruiting
First Posted : August 28, 2019
Last Update Posted : January 18, 2023
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Sponsor:
Alpha Tau Medical LTD.
Information provided by (Responsible Party):
Alpha Tau Medical LTD.
| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | August 19, 2019 | |||||||||
| First Posted Date ICMJE | August 28, 2019 | |||||||||
| Last Update Posted Date | January 18, 2023 | |||||||||
| Actual Study Start Date ICMJE | April 1, 2022 | |||||||||
| Estimated Primary Completion Date | January 2024 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
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)
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| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures |
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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| Original Other Pre-specified Outcome Measures | Same as current | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Alpha Radiation Emitters Device for the Treatment of of Malignant Cutaneous Tumors | |||||||||
| Official Title ICMJE | A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous Tumors | |||||||||
| Brief Summary | A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for Malignant Cutaneous Tumors | |||||||||
| Detailed Description | 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). |
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| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Not Applicable | |||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Device: DaRT- Diffusing Alpha-emitters Radiation Therapy
Seed(s) loaded with Radium-224 for local intratumoral irradiation with the destructive power of alpha particles
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| Study Arms ICMJE | 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.
Intervention: Device: DaRT- Diffusing Alpha-emitters Radiation Therapy
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Recruiting | |||||||||
| Estimated Enrollment ICMJE |
80 | |||||||||
| Original Estimated Enrollment ICMJE | Same as current | |||||||||
| Estimated Study Completion Date ICMJE | January 2024 | |||||||||
| Estimated Primary Completion Date | January 2024 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | France | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT04068155 | |||||||||
| Other Study ID Numbers ICMJE | CTP-MCT-00 | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Current Responsible Party | Alpha Tau Medical LTD. | |||||||||
| Original Responsible Party | Same as current | |||||||||
| Current Study Sponsor ICMJE | Alpha Tau Medical LTD. | |||||||||
| Original Study Sponsor ICMJE | Same as current | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| PRS Account | Alpha Tau Medical LTD. | |||||||||
| Verification Date | April 2022 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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