A Study Evaluating a New Radiation Treatment Workflow (NGDS) (SPEED)

Varian

Status: Enrolling

Conditions: Lung Cancer (Diagnosis); Abdominal Cancer; Liver Cancer, Adult; Thoracic Cancers; Pancreatic Cancer

Treatments: Device: Next Generation Delivery System (NGDS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07824583

VAR-2025-01

Details and patient eligibility

About

The purpose of this research is to evaluate the "Next Generation Delivery System" (NGDS) and determine if this machine will be more efficient at delivering radiation in shorter treatment time and better patient tolerance, with less breath holding.

Full description

This study is a prospective multi-center clinical trial. It is designed to evaluate the feasibility of a breath hold workflow on a new treatment platform (NGDS DMAT).

Eligible participants will be receiving stereotactic body radiotherapy (SBRT) under breath hold conditions to targets in the thorax and upper abdomen as part of their routine care.

Enrolled participants will be asked to undergo a mock treatment on this new treatment platform under breath hold conditions. Participant images for set up and alignment will be obtained on the NGDS.

Enrollment: 20 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Target lesions in the thorax or upper abdomen
2. Planned to undergo SBRT radiation treatment delivered on a conventional "C-arm" or ring gantry CBCT guided linear accelerator under breath hold conditions
3. ECOG performance status 0-1
4. At least 21 years of age
5. Able to sign informed consent

Exclusion criteria

1. Participants enrolled in another clinical investigation the investigator believes to be in conflict with this clinical investigation.
2. Participants with any other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical investigation.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Single Arm - All patients will be treated the same

Other group

Description:

"Mock" treatment on the NGDS machine.

Treatment:

Device: Next Generation Delivery System (NGDS)