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NCT Number: NCT07824583

A Study Evaluating a New Radiation Treatment Workflow (NGDS)

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.

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Key information

Conditions

Lung Cancer (Diagnosis) Abdominal Cancer Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Disease Endocrine Gland Neoplasms Endocrine System Diseases Liver Cancer, Adult Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Cancers Thoracic Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Siteman Cancer Center Washington University, St Louis, Missouri, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Participants enrolled in another clinical investigation the investigator believes to be in conflict with this clinical investigation.
  • 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.

Treatment and study plan

Next Generation Delivery System (NGDS)

Device

Participant will receive a "mock" treatment on the NGDS machine. Participant will complete experience questionnaires.

Primary outcomes

  1. To evaluate the feasibility of the mock NGDS DMAT workflow under breath hold conditions.

    Time frame: From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months

    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

Secondary outcomes

  1. To quantify the number of breath holds required.

    Time frame: From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months

    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.

  2. To assess the participant's experience of the conventional treatment and mock NGDS DMAT treatment.

    Time frame: From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months

    Participant survey to assess the experience of treatment on the conventional machine and mock treatment on the NGDS.

  3. To quantify all temporal aspects of the NGDS DMAT and conventional treatment sessions.

    Time frame: From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months

    Measuring and recording the time required for each workflow step in both conventional treatment and mock NGDS DMAT treatment.

  4. To create a DMAT dosimetry plan judged clinically acceptable for treatment.

    Time frame: From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months

    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.

  5. To assess patient-specific quality assurance results for DMAT plans.

    Time frame: From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months

    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).

  6. To assess the feasibility of intra-fraction motion monitoring with triggered imaging.

    Time frame: From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Woo

CONTACT

[email protected]

437-991-3496

Sponsors and collaborators

Lead sponsor

Varian, a Siemens Healthineers Company

Industry

Registry information

Official study title

A ProSPEctivE Study of NGDS DMAT Workflow Feasibility

Acronym: SPEED

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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