Actively Recruiting
A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia
Led by Alpha Tau Medical LTD. · Updated on 2025-02-07
56
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a unique cancer treatment using an intratumoral diffusing alpha radiation emitter device called DaRT for patients with superficial malignant tumors in the skin, mucosal areas like the oral cavity, or soft tissue. This prospective, open-label, single-arm study aims to assess the safety and effectiveness of this therapy, which delivers alpha radiation directly inside tumors through radioactive seeds. The treatment is designed to combine benefits of local radiation with the targeted power of alpha-emitting atoms at lower doses than traditional radiation therapies. The study involves inserting DaRT seeds, loaded with Radium-224, directly into the tumor where they release short-lived alpha-emitting atoms to attack cancer cells. Eligible tumors must be 7 centimeters or smaller and suitable for full coverage by the seeds. This treatment is for patients with confirmed malignant lesions who have either not responded to first-line treatments, cannot undergo standard therapies, or choose not to receive them. The study tracks tumor response around 9 to 11 weeks after seed insertion and monitors safety over up to 24 months. Participants will undergo assessments including tumor size measurement, quality of life questionnaires at multiple points up to 180 days post-treatment, and monitoring for any adverse events. Placement of DaRT seeds is verified on the day of the procedure. Researchers also evaluate progression-free survival over two years. The study requires patients to have certain health markers and performance status and includes safety monitoring for side effects throughout the follow-up period. Total participation spans from initial treatment through long-term observation.
CONDITIONS
Brief Title
Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects with histopathological confirmation of primary or secondary malignant cutaneous, oral mucosal, or superficial soft tissue tumors within 6 months before treatment
- Tumor size 7 centimeters or smaller in longest diameter
- Lesion must be suitable for full coverage by DaRT seeds
- Brachytherapy indication approved by a multidisciplinary team
- Patients who failed first-line treatment, are unfit for standard care, or refuse standard care
- Measurable disease per RECIST v1.1
- Age 18 years or older
- ECOG Performance Status less than 2
- Life expectancy over 6 months
- Platelet count at least 100,000/mm3
- White blood cell count at least 3500/µl and granulocytes at least 1500/µl
- AST and ALT less than or equal to 2.5 times upper limit of normal
- INR of prothrombin time less than or equal to 1.8
- Creatinine less than or equal to 1.9 mg/dL
- Women of childbearing potential must have a negative pregnancy test and use contraception for 3 months after treatment
- Willingness to sign informed consent
You will not qualify if you...
- Tumor with Keratoacanthoma histology
- Known allergy to any treatment components
- Significant cardiovascular disease including severe heart failure, uncontrolled coronary disease, cardiomyopathy, arrhythmias, hypertension, or recent heart attack
- Medical or psychiatric conditions that impair ability to tolerate treatment or affect study goals
- Ongoing systemic immunosuppressive therapy except brief corticosteroid use
- Treatments that may interfere with study outcomes
- Participation in conflicting interventional studies within past 30 days
- Inability or unwillingness to use adequate contraception during and 3 months after study
- High risk of protocol non-compliance
- Refusal to sign informed consent
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive intratumoral insertion of radioactive DaRT seeds to treat malignant cutaneous, mucosal, or superficial soft tissue tumors.
1 procedure visit (in-person)
Duration - Up to 24 months
Participants are monitored for tumor response, safety, and quality of life changes after DaRT seed insertion.
Visits on Day 15, Day 30, Day 70, Day 180, and regular assessments up to 24 months
Trial Site Locations
Total: 1 location
1
Sharett institute, Hadassah Medical Center - Ein-Kerem
Jerusalem, Israel, 91120
Actively Recruiting
Research Team
L
Liron Dimnik
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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