A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva.
This is an prospective Open label, single arm, multi center, interventional study treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva .The study objectives are to collect data on the Feasibility and Safety of DaRT among patients who do not fit the entry of existing investigational trials. The primary endpoint of the study is to evaluate the feasibility and safety of the Alpha DaRT sources for the treatment of vulva SCC. Feasibility will be determined according to the rate of successful placement of Alpha DaRT . Safety will be determined according to the overall incidence of device related AEs and SAE's graded according to CTCAE v5.0 criteria. The Secondary endpoint of the study will be to evaluate efficacy, as determined by local control evaluation according to RECIST v1.1
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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
Feasibility - DaRT seed placement
Feasibility will be determined according to the rate of successful placement of Alpha DaRT
Time frame: immediately following the insertion procedure
Safety - Adverse events
Safety will be determined according to the overall incidence of device related AEs and SAE's graded according to CTCAE v5.0 criteria.
Time frame: From day 0
Efficacy -Alpha DaRT seeds
The study's secondary objective will be to evaluate efficacy, as determined by local control evaluation according to RECIST v1.1
Time frame: 1, 3, and 6 months post DaRT insertion].
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