Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia
A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia
1 other identifier
interventional
56
1 country
1
Brief Summary
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2020
CompletedFirst Posted
Study publicly available on registry
September 1, 2020
CompletedStudy Start
First participant enrolled
December 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedFebruary 7, 2025
November 1, 2024
5 years
August 18, 2020
February 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Tumor response to DaRT
Assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
9-11 weeks post DaRT insertion
Adverse Events
The incidence, frequency, severity and causality of acute adverse events related to the DaRT treatment according to Common Terminology and Criteria for adverse events (CTCAE) version 5.0.
Up to 24 Months
Secondary Outcomes (5)
Change in tumor volume
9-11 weeks post DaRT insertion
DaRT seeds placement
1 Day of procedure
Change in quality of life
Day 15, Day 30, Day 70, Day 180 post DaRT insertion
Change in quality of life
Day 30, Day 70, Day 180 post DaRT insertion
Progression Free Survival
24 months post DaRT insertion
Other Outcomes (1)
Adverse Events
Up to 24 Months
Study Arms (1)
DaRT Seeds
EXPERIMENTALIntratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sharett institute, Hadassah Medical Center - Ein-Kerem
Jerusalem, 91120, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aron Popovtzer
Sharett institute, Hadassah University Hospital - Ein-Kerem
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2020
First Posted
September 1, 2020
Study Start
December 22, 2020
Primary Completion
January 1, 2026
Study Completion
January 1, 2026
Last Updated
February 7, 2025
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share