NCT03349892

Stereotactic Ablative Radiotherapy for Refractory Ventricular Tachycardia

Stereotactic Ablative Radiotherapy (SABR) for Refractory Ventricular Tachycardia - a Phase I/II Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Single arm, phase Ib/2a dose escalation study with an expansion cohort to determine the maximal tolerated dose (MTD) for stereotactic ablative radiotherapy of targets in the cardiac myocardium and to make a preliminary assessment of the efficacy of the treatment. The dose escalation will be guided by Time-to-Event Continual Reassessment Method (TITE-CRM) to ensure more patients will be spared dose limiting toxicities and more patients will be entered on the dose level that will be chosen as minimal dose of maximal effect. This design also allows for continual accrual of patients when delayed adverse events may be observed.

Conditions

• Refractory Ventricular Tachycardia

Interventions

Type	Name	Description
RADIATION	Stereotactic Ablative Radiotherapy (SABR)	A single fraction of radiation is delivered using a clinical radiotherapy system capable of stereotactic radiotherapy to the chest, with on-board image guided radiotherapy capabilities, respiratory motion management, and Intensity Modulated Radiotherapy Treatment (IMRT) planning.

Timeline

• Start date: 2017-04-01
• Primary completion: 2019-08-06
• Completion: 2019-08-06
• First posted: 2017-11-22
• Last updated: 2021-11-15
• Results posted: 2021-11-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study