NCT04534127 Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia
| NCT ID | NCT04534127 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Alpha Tau Medical LTD. |
| Condition | Skin Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2020-12-22 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 56 participants in total. It began in 2020-12-22 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia
Eligibility Criteria
Inclusion Criteria: * Subjects with histopathological confirmation of primary or secondary malignant cutaneous neoplastic lesions, or oral cavity mucosal tumors, or superficial soft tissue sarcoma. Confirmation obtained within 6 months of planned treatment. * Subjects with a tumor size ≤ 7 centimeters in the longest diameter. * Targetable lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds * Brachytherapy indication validated by a multidisciplinary team * Patients who have either failed first-line treatment, or are medically unfit for standard of care (surgery, external-beam radiation therapy or chemotherapy), or refuse standard of care. * 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. * WBC ≥ 3500/μl, granulocyte ≥ 1500/μl * AST and ALT ≤ 2.5 X ULN * International normalized ratio of prothrombin time ≤1.8. * Creatinine ≤1.9 mg/dL. Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test 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: * Subject has a tumor of Keratoacanthoma histology. * 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 the last 12 months. * Any medical or psychiatric illness which in the opinion of the investigator would compromise the patient's ability to tolerate this treatment or interfere with the study endpoints. * Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids * Patient requires treatment which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT * Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT. * Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy. * High probability of protocol non-compliance (in opinion of investigator). * Subjects not willing to sign an informed consent. * Women who are pregnant or breastfeeding.
Contact & Investigator
Aron Popovtzer
PRINCIPAL INVESTIGATOR
Sharett institute, Hadassah University Hospital - Ein-Kerem
Frequently Asked Questions
Who can join the NCT04534127 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Skin Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04534127 currently recruiting?
Yes, NCT04534127 is actively recruiting participants. Contact the research team at LironD@alphatau.com for enrollment information.
Where is the NCT04534127 trial being conducted?
This trial is being conducted at Jerusalem, Israel.
Who is sponsoring the NCT04534127 clinical trial?
NCT04534127 is sponsored by Alpha Tau Medical LTD.. The principal investigator is Aron Popovtzer at Sharett institute, Hadassah University Hospital - Ein-Kerem. The trial plans to enroll 56 participants.
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