NCT05125354

A Retrospective Analysis to Evaluate Long Term Outcomes of SCC Patients Previously Treated With Alpha DaRT

A Retrospective Analysis to Evaluate Long Term Outcomes of Squamous Cell Carcinoma Patients Previously Treated With Alpha Diffusing Alpha-emitters Radiation Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 33 (actual)
• Sponsor: Alpha Tau Medical LTD. · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of long-term efficacy outcomes of patients previously treated with the Alpha DaRT seeds for management of their malignancy following initial response.

Detailed description

Medical records of patients that previously underwent the Alpha DaRT treatment will be reviewed by an authorized staff member. Evaluation of long-term outcomes of patients previously treated with the Alpha DaRT seeds for management of their malignancy following initial response. These outcomes include: * Safety - assessment of late onset of Alpha DaRT related AE in patients treated with the Alpha DaRT seeds * Efficacy - * assessment of local recurrence rates in patients who achieved initial complete response (CR) following the Alpha DaRT treatment * assessment of duration of response in patients who achieved initial CR following the Alpha DaRT treatment * assessment of survival status in patients treated with the Alpha DaRT seeds

Conditions

• Squamous Cell Carcinoma
• DaRT Treated Patients

Timeline

• Start date: 2022-01-06
• Primary completion: 2022-03-06
• Completion: 2022-03-06
• First posted: 2021-11-18
• Last updated: 2022-06-01

Locations

2 sites across 2 countries: Israel, Italy