Alpha Radiation Emitters Device (DaRT) for the Treatment of Recurrent Lung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlpha Tau Medical LTD.
About this trial
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for treatment of recurrent Lung Cancer .
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically and/or cytologically proven recurrent mediastinal tumors
Target lesion is technically amenable for at least 50% coverage by the Alpha DaRT seeds as determined by the treating physician
Up to two treatable lesions
Interstitial radiation indication validated by a multidisciplinary team.
Disqualifiers
Concomitant chemotherapy or immunotherapy
Brain metastases Connective tissue disease (scleroderma, lupus)
Known hypersensitivity to any of the components of the treatment.
Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
Trial design
Design model
Single group
Treatments tested in this trial
Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
DeviceAn 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
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: DaRT SeedsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility - 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 902
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 90Secondary outcomes
1
Efficacy - Alpha DaRT seeds
Local control evaluation according to RECIST v1.1
Time frame
1 month and 3 months2
Efficacy - Alpha DaRT seeds
Tumor Coverage
Time frame
Day 0-Day 90Sponsors and contacts
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Source ClinicalTrials.gov