A Study Evaluating a New Radiation Treatment Workflow (NGDS)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorVarian, a Siemens Healthineers Company

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • Next Generation Delivery System (NGDS)

    Device

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Single Arm - All patients will be treated the sameOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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