A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Davidof Cancer Institution at the Rabin Medical Center Israel
Petah Tikva, Israel
Tumor response to DaRT
Assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
Time frame: 9-11 weeks post DaRT insertion
Adverse Events
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.
Time frame: Up to 24 Months
Reduction in tumor volume
based on imaging
Time frame: 9-11 weeks post DaRT insertion
DaRT seeds placement
Assessment by localization of the DaRT seeds in the tumor using CT imaging on the day of DaRT insertion
Time frame: Day of insertion procedure
Change in quality of life
Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skindex-16 questionnaire score
Time frame: Day 15, Day 30, Day 70, Day 180 post DaRT insertion
Change in quality of life
Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skin Cancer Index (SCI) questionnaire score
Time frame: Day 30, Day 70, Day 180 post DaRT insertion
Adverse Events
All Adverse Events (AE) related and unrelated to the study treatment
Time frame: Up to 24 Months
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Progression Free Survival
Time elapsed from response to disease progression
Time frame: 24 months post DaRT insertion