An interventional study of Next Generation Delivery System (NGDS) in Lung Cancer (Diagnosis), Liver Cancer, Adult and Pancreatic Cancer, sponsored by Varian, a Siemens Healthineers Company. Recruiting at 2 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Varian, a Siemens Healthineers Company (part of Siemens Healthineers) · Not applicable, Interventional, and Device 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.
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.
5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 3,656 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Varian, a Siemens Healthineers Company is the lead sponsor of 29 studies on the registry; 8 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
First submitted after Varian became part of Siemens Healthineers.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
"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.
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: 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
Time frame: From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months
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.
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.
Participant survey to assess the experience of treatment on the conventional machine and mock treatment on the NGDS.
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.
Measuring and recording the time required for each workflow step in both 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 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.
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.
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).
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.
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).
Time frame: From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months
Plan to share: Undecided — Data is highly confidential however any publication plans will follow ICMJE guidelines.
No publications or documents are linked to this record.
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