Alpha Radiation Emitters Device for the Treatment of Squamous Cell Carcinoma (DaRT)
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|ClinicalTrials.gov Identifier: NCT03015883|
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : December 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma||Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)||Not Applicable|
This will be a prospective, first in man, controlled study, assessing the safety and efficacy 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.
Lesions with histopathological diagnosis of squamous cell carcinoma will be studied.
Reduction in tumor size 30 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)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Squamous Cell Carcinoma (First in Man)|
|Actual Study Start Date :||February 22, 2017|
|Actual Primary Completion Date :||June 1, 2019|
|Actual Study Completion Date :||June 25, 2019|
Experimental: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seed Devices
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
- Adverse Events [ Time Frame: 30-45 days post seed insertion ]The incidence, severity and frequency of all Adverse Events
- Reduction in Tumor size [ Time Frame: 30-45 days post seed insertion ]The reduction in tumor size 30-45 days after DaRT insertion
- Percent of NecroticTissue [ Time Frame: 30-45 days post seed insertion ]Percent of necrotic tissue in the tumor 30 days after DaRT insertion
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): NCT03015883
|Davidof Cancer Institution at the Rabin Medical Center Israel|
|Petah Tiqva, Israel, 49100|
|Principal Investigator:||Aharon Popovtzer, MD||Davidof Cancer Institution at the Rabin Medical Center Israel|