NCT04068155

Alpha Radiation Emitters Device for the Treatment of of Malignant Cutaneous Tumors

A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous Tumors

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Alpha Tau Medical LTD. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for Malignant Cutaneous Tumors

Detailed description

This will be a prospective, open label, single arm, multi- center study, assessing the safety and effectiveness of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor. This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients. Cutaneous lesions with histopathological confirmation of malignancy will be treated using DaRT seeds. Reduction in tumor size 9-11 weeks following DaRT insertion will be assessed. Safety will be assessed by the frequency, severity and causality of all Adverse Events (AE).

Conditions

• Skin Cancer
• Cutaneous Tumor
• Cutaneous Metastasis

Interventions

Type	Name	Description
DEVICE	DaRT- Diffusing Alpha-emitters Radiation Therapy	Seed(s) loaded with Radium-224 for local intratumoral irradiation with the destructive power of alpha particles

Timeline

• Start date: 2022-04-01
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2019-08-28
• Last updated: 2024-11-22

Locations

2 sites across 1 country: France