A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for treatment of recurrent Lung Cancer .
This is a prospective , interventional, open label, single arm, single center study. The study is designed to evaluate the Feasibility and Safety of DaRT seeds for the treatment of Recurrent Lung Cancer. The study will be comprised of a screening period, DaRT insertion visit, acute follow-up phase of 4- 8 weeks and a long-term follow up phase of 3 months. The total duration of the study will be 3 months from the DaRT insertion procedure. A total of 10 subjects will be enrolled to the study . Eligible patients who meet inclusion/exclusion criteria (as assessed during the screening period) will be invited to the site for the procedure of DaRT seeds insertion. The patients will be monitored for a period of 3 months post insertion
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
An intratumoral insertion of radioactive sources \[Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)\]. The seeds release by recoil into the tumor short-lived alpha-emitting atoms
Hadassah University Hospital
Jerusalem, Israel
RECRUITINGFeasibility - DaRT seed placement
Feasibility will be determined according to the rate of successful placement of DaRT seeds via imaging
Time frame: From Day 0-Day 90
Safety- Adverse events
Safety will be determined according to the overall incidence of device related SAE's graded according to CTCAE v5.0 criteria
Time frame: From Day 0-Day 90
Efficacy - Alpha DaRT seeds
Local control evaluation according to RECIST v1.1
Time frame: 1 month and 3 months
Efficacy - Alpha DaRT seeds
Tumor Coverage
Time frame: Day 0-Day 90
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