Lung Cancer (Diagnosis)SPEEDNCT07824583
A Study Evaluating a New Radiation Treatment Workflow (NGDS)
A study testing Next Generation Delivery System (NGDS) in people with Lung Cancer (Diagnosis) and Liver Cancer, Adult, run by Varian, a Siemens Healthineers Company at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Lung Cancer (Diagnosis), Liver Cancer, Adult, Pancreatic Cancer
- What is being tested?
- Next Generation Delivery System (NGDS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jul 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University Hospital Cleveland Medical Center
Cleveland, Ohio, 44106
Carly Croyle, BS, 216-844-7087, Carly.Croyle@UHhopsitals.org
Lauren Henke
- Recruiting
Siteman Cancer Center Washington University
St Louis, Missouri, 63108
Pamela Samson
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer (Diagnosis), Liver Cancer, Adult, Pancreatic Cancer, Thoracic Cancers, Abdominal Cancer
- Being tested
- Next Generation Delivery System (NGDS)
- Keywords
- Stereotactic body radiation therapy, Lung cancer, Liver cancer, Pancreatic cancer, Thoracic cancer, abdominal cancer, Breath hold, DMAT, linac, motion monitoring, linear accelerator, kV fluoroscopy, C-arm
- Medical subject headings
- Lung Neoplasms, Disease, Carcinoma, Hepatocellular, Pancreatic Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next Generation Delivery System (NGDS)Device
Participant will receive a "mock" treatment on the NGDS machine. Participant will complete experience questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm - All patients will be treated the same | Other | "Mock" treatment on the NGDS machine. Receives: Device: Next Generation Delivery System (NGDS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start31 Jul 2026
- Primary completionFeb 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Varian, a Siemens Healthineers Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824583
- Sponsor's protocol ID
- VAR-2025-01
- Acronym
- SPEED
- Status last verified
- Sep 2026
- First submitted
- 19 Aug 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Data is highly confidential however any publication plans will follow ICMJE guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A ProSPEctivE Study of NGDS DMAT Workflow Feasibility
- ClinicalTrials.gov ID
- NCT07824583
- Acronym / sponsor ID
- SPEED / VAR-2025-01
- Conditions
- Lung Cancer (Diagnosis), Liver Cancer, Adult, Pancreatic Cancer, Thoracic Cancers, Abdominal Cancer
- Keywords
- Stereotactic body radiation therapy, Lung cancer, Liver cancer, Pancreatic cancer, Thoracic cancer, abdominal cancer, Breath hold, DMAT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Varian, a Siemens Healthineers CompanyIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm - All patients will be treated the same | Other | Device: Next Generation Delivery System (NGDS)"Mock" treatment on the NGDS machine. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Next Generation Delivery System (NGDS)Participant will receive a "mock" treatment on the NGDS machine. Participant will complete experience questionnaires. | Device | Single Arm - All patients will be treated the same |
Primary outcome
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: 1. Acquisition of an IDENTIFY-monitored breath hold kV HyperSight CBCT 2. Conduct verification imaging of shifts and breath hold position using kV fluoroscopy 3. Delivery of an investigator approved "mock" DMAT treatment plan
6 secondary outcomes
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Undecided. Data is highly confidential however any publication plans will follow ICMJE guidelines.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Next Generation Delivery System (NGDS) in people with Lung Cancer (Diagnosis) and Liver Cancer, Adult, run by Varian, a Siemens Healthineers Company at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Woo (437-991-3496, jennifer.woo@siemens-healthineers.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.