Retreatment With Intratumoral Diffusing Alpha Radiation Emitters
Israel2 participantsStarted 2020-12-22
Plain-language summary
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects with histopathological confirmation of either recurrent or persistent disease following DaRT treatment.
* Subjects with a tumor size ≤ 5 centimeters in the longest diameter.
* Target lesion technically amenable for full coverage with the Alpha DaRT seeds.
* Brachytherapy indication validated by a multidisciplinary team.
* Measurable disease according to RECIST v1.1.
* Subjects over 18 years old.
* Subjects' ECOG Performance Status Scale is \< 2.
* Subjects' life expectancy is more than 6 months.
* Platelet count ≥100,000/mm3.
* AST and ALT ≤ 2.5 X ULN
* WBC ≥ 3500/μl, granulocyte ≥ 1500/μl
* International normalized ratio of prothrombin time ≤1.4 for patients not on Warfarin
* Creatinine ≤2.3 mg/dL.
* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after brachytherapy.
* Subjects are willing to sign an informed consent form.
Exclusion Criteria:
* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids
* Known hypersensitivity to any of the components of the treatment.
* Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in…
What they're measuring
1
Tumor response to DaRT
Timeframe: 9-11 weeks post DaRT insertion
2
Adverse events
Timeframe: From conscent up to 9-11 weeks post DaRT insertion