A Novel Method for Treating Lung Met w/Combo of Electric Fields & Rad Therapy: A Single-Arm
NCT05555342 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2025-05-14
Summary
This is a phase 0, pilot prospective study to determine the feasibility of combined irreversible electroporation (IRE) and radiation therapy in subjects with lung tumors with metastatic cancer of any histology. These are subjects who have advanced disease (stage IV) or previously treated disease that has become progressive, recurrent, or metastatic.
Conditions
- Lung Tumor
- Metastatic Cancer
Interventions
- PROCEDURE
-
Irreversible electroporation (IRE) ablation
IRE will be performed using the NanoKnife or Aliya System. CT or cone-beam CT will be used to direct electrode placement.
- RADIATION
-
Radiation Therapy
Moderate-dose radiation therapy to the target tumor(s) in 1 fraction.
Sponsors & Collaborators
-
University of California, Irvine
lead OTHER
Principal Investigators
-
Jeremy Harris, MD · Chao Family Comprehensive Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-03
- Primary Completion
- 2023-09-29
- Completion
- 2024-10-27
- FDA Device
- Yes
Countries
- United States
Study Locations
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