Alpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia (DaRT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03737734|
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : March 16, 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 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|
|Actual Study Start Date :||December 31, 2018|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 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: Up to 24 Months ]The incidence, frequency, severity and causality of acute adverse events related to the DaRT treatment according to Common Terminology and Criteria for adverse events (CTCAE) version 5.0.
- Reduction in tumor volume [ Time Frame: 9-11 weeks post DaRT insertion ]based on imaging
- DaRT seeds placement [ Time Frame: Day of insertion procedure ]Assessment 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: Day 15, Day 30, Day 70, Day 180 post DaRT insertion ]Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skindex-16 questionnaire score
- Change in quality of life [ Time Frame: Day 30, Day 70, Day 180 post DaRT insertion ]Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skin Cancer Index (SCI) questionnaire score
- Adverse Events [ Time Frame: Up to 24 Months ]All Adverse Events (AE) related and unrelated to the study treatment
- Progression Free Survival [ Time Frame: 24 months post DaRT insertion ]Time elapsed from response to disease progression
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): NCT03737734
|Contact: Adi Cohenemail@example.com|
|Contact: Naama Barelfirstname.lastname@example.org|
|Davidof Cancer Institution at the Rabin Medical Center Israel||Recruiting|
|Petah tikva, Israel, 49100|
|Contact: Noga Korman, MD +972-526630974 NogaKu1@clalit.org.il|
|Principal Investigator:||Noga Kurman, MD||Davidof Cancer Institution at Rabin Medical Center Israel|