Retreatment With Intratumoral Diffusing Alpha Radiation Emitters
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|ClinicalTrials.gov Identifier: NCT04540588|
Recruitment Status : Recruiting
First Posted : September 7, 2020
Last Update Posted : January 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Skin Cancer Mucosal Neoplasm of Oral Cavity Soft Tissue Neoplasm||Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)||Not Applicable|
This will be a prospective, open label, single arm, controlled study, assessing the safety and efficacy of re-treatment with 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.
Superficial lesions with histopathological confirmation of either recurrent or persistent disease following DaRT treatment. .
Reduction in tumor size 70 days after DaRT insertion will be assessed. Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Safety and Efficacy Study of Retreatment With Intratumoral Diffusing Alpha Radiation Emitters|
|Actual Study Start Date :||December 22, 2020|
|Estimated Primary Completion Date :||January 1, 2023|
|Estimated Study Completion Date :||January 1, 2024|
Experimental: DaRT Seeds
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.
Other Name: DaRT
- Tumor response to DaRT [ Time Frame: 9-11 weeks post DaRT insertion ]Assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
- Adverse events [ Time Frame: From conscent up to 9-11 weeks post DaRT insertion ]Frequency, severity and causality of acute adverse events 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.
- Change in tumor volume [ Time Frame: 9-11 weeks post DaRT insertion ]Based on imaging
- Local control rate [ Time Frame: 9-11 weeks post DaRT insertion ]Will be assessed as the number of complete responses, partial responses and stable disease divided by the total numbers of tumors treated.
- Adverse Events [ Time Frame: From conscent up to 9-11 weeks post DaRT insertion ]Incidence of all Adverse Events (AE) related and unrelated to the study treatment.
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): NCT04540588
|Contact: Adi Cohenfirstname.lastname@example.org|
|Contact: Naama Barelemail@example.com|
|Sharett institute, Hadassah University Hospital - Ein-Kerem||Recruiting|
|Jerusalem, Israel, 91120|
|Contact: Aron Popovtzer, MD|
|Principal Investigator:||Aron Popovtzer, M.D||Sharett institute, Hadassah Medical Center - Ein-Kerem|