ClinicalTrialsFinder
RecruitingNot ApplicableNCT03889899

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

Sponsor

Alpha Tau Medical LTD.

Enrollment

30 participants

Start Date

Oct 21, 2020

Study Type

INTERVENTIONAL

Conditions

Skin CancerMucosal Neoplasm of Oral CavitySoft Tissue Neoplasm

Summary

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia

Eligibility

Min Age: 18 Years

Inclusion Criteria11

  • Subjects with histopathological confirmation of primary or secondary malignant cutaneous neoplastic lesions, or oral cavity mucosal tumors, or superficial soft tissue sarcoma.
  • Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
  • 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.
  • 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.
  • Subjects are willing to sign an informed consent form.

Exclusion Criteria7

  • Subject has a tumor of Keratoacanthoma histology.
  • Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.)
  • Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids
  • 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.
  • High probability of protocol non-compliance (in opinion of investigator).
  • Subjects not willing to sign an informed consent.
  • Women who are pregnant or breastfeeding.

Interventions

DEVICERadiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

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.

Locations(1)

RAMBAM Health Care Campus

Haifa, Israel

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03889899

Related Trials

Early Phase Study of KESONOTIDE™in Participants With Solid Tumours

NCT069260753 locations

Prospective Registry of Histotripsy for Soft Tissue Tumors

NCT074700081 location

The Florida ASCENT Study

NCT070422431 location

Circulating Tumor DNA (ctDNA) for Early Treatment Response Assessment of Solid Tumors

NCT043540641 location

Immunotherapy Efficacy and PD-L1 as a Predictive Biomarker in Metastatic Melanoma in Slovenia

NCT074227791 location