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

A ProSPEctivE Study of NGDS DMAT Workflow Feasibility

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer; Abdominal Cancer; Lung Cancer (Diagnosis); Liver Cancer, Adult; Thoracic Cancers
• Intervention / Treatment: Device: Next Generation Delivery System (NGDS)

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Woo; Phone Number: 437-991-3496; Email: jennifer.woo@siemens-healthineers.com

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63108
      • Recruiting
      • Siteman Cancer Center Washington University
      • Principal Investigator: Pamela Samson
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospital Cleveland Medical Center
      • Principal Investigator: Lauren Henke
      • Contact: Carly Croyle, BS; Phone Number: 216-844-7087; Email: Carly.Croyle@UHhopsitals.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single Arm - All patients will be treated the same; "Mock" treatment on the NGDS machine.	Device: Next Generation Delivery System (NGDS); Participant will receive a "mock" treatment on the NGDS machine. Participant will complete experience questionnaires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the feasibility of the mock NGDS DMAT workflow under breath hold conditions.	Feasibility of the mock NGDS DMAT treatment workflow under breath hold conditions will be confirmed following successful execution of each step: Acquisition of an IDENTIFY-monitored breath hold kV HyperSight CBCT; Conduct verification imaging of shifts and breath hold position using kV fluoroscopy; Delivery of an investigator approved "mock" DMAT treatment plan	From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To quantify the number of breath holds required.	Record and compare the number of breath holds required by the participant to complete treatment beam delivery on the NGDS to the number of breath holds required on the conventional treatment machine.	From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months
To assess the participant's experience of the conventional treatment and mock NGDS DMAT treatment.	Participant survey to assess the experience of treatment on the conventional machine and mock treatment on the NGDS.	From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months
To quantify all temporal aspects of the NGDS DMAT and conventional treatment sessions.	Measuring and recording the time required for each workflow step in both conventional treatment and mock NGDS DMAT treatment.	From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months
To create a DMAT dosimetry plan judged clinically acceptable for treatment.	The NGDS DMAT plan must be judged by the attending physician to be clinically similar to the conventional SBRT plan (i.e. the same clinical goals will be used to evaluate both plans), and acceptable for treatment.	From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months
To assess patient-specific quality assurance results for DMAT plans.	Delivery quality assurance and dose calculation accuracy will be measured by institutional-specific QA equipment (compliant with AAPM (American Association of Physicists in Medicine) Task Group 218).	From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months
To assess the feasibility of intra-fraction motion monitoring with triggered imaging.	Success of intra-fraction motion monitoring imaging will be measured by the ability to carry out triggered imaging in one second intervals (or as dictated by the treatment plan).	From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months

Collaborators and Investigators

• Sponsor: Varian, a Siemens Healthineers Company

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: August 19, 2026
• First Submitted That Met QC Criteria: September 14, 2026
• First Posted (Actual): September 17, 2026

Study Record Updates

• Last Update Posted (Actual): September 17, 2026
• Last Update Submitted That Met QC Criteria: September 14, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Lung cancer; Pancreatic cancer; Liver cancer; Stereotactic body radiation therapy; Thoracic cancer; abdominal cancer; DMAT; C-arm; motion monitoring; Breath hold; linear accelerator; linac; kV fluoroscopy
• Additional Relevant MeSH Terms: Endocrine System Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Lung Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma; Pathological Conditions, Signs and Symptoms; Carcinoma, Hepatocellular; Lung Neoplasms; Disease; Pancreatic Neoplasms; Liver Neoplasms
• Other Study ID Numbers: VAR-2025-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data is highly confidential however any publication plans will follow ICMJE guidelines.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes