Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia.
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|ClinicalTrials.gov Identifier: NCT03889899|
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : July 10, 2020
|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 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 malignancy will be treated using DaRT seeds.
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 :||30 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, Mucosal or Superficial Soft Tissue Neoplasia|
|Estimated Study Start Date :||July 2020|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||September 2022|
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.
- Tumor response to DaRT [ Time Frame: 9-11 weeks after DaRT seed insertion. ]Assessment of the rate of malignant cutaneous, mucosal or superficial soft tissue tumors response using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
- Adverse Events [ Time Frame: Time Frame: 9-11 weeks post DaRT insertion. ]The incidence, frequency, severity and causality of acute adverse events related to the DaRT treatment
- Assessment of the reduction in tumor volume [ Time Frame: 9-11 weeks follow-up visit. ]Assessment of the reduction in tumor volume based on CT / PET-CT measured tumor volume
- DaRT seeds placement. [ Time Frame: Day of insertion procedure. ]Assessment of the DaRT seeds placement by localization of the DaRT seeds in the tumor using CT imaging on the day of DaRT insertion.
- Change in quality of life [ Time Frame: Screening, DaRT removal and day 70 visits. ]Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skindex-16 questionnaire score. An overall score ranging from 0 (best) to 100 (worst).
- Change in quality of life [ Time Frame: Screening, DaRT removal and day 70 visits. ]Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skin Cancer Index (SCI) questionnaire score. An overall score ranging from 0 (best) to 100 (worst).
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): NCT03889899
|Contact: Naama Barel||+972-3-618-24770||Naamab@alphatau.com|
|RAMBAM Health Care Campus||Recruiting|
|Haifa, Israel, 3109601|
|Contact: Tomer Charas, MD +972-4-777-6505 firstname.lastname@example.org|
|Principal Investigator: Tomer Charas, MD|
|Principal Investigator:||Tomer Charas, MD||Radiotherapy unit at Rambam Health Care Campus, Israel|