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Use of AlignRT System During Stereotactic Radiosurgery

Use of AlignRT System During Stereotactic Radiosurgery

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07716124
Enrollment
20
Registered
2026-07-21
Start date
2025-04-01
Completion date
2025-08-31
Last updated
2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Metastases

Keywords

Stereotactic Radiosurgery, Surface-Guided Radiation Therapy, AlignRT

Brief summary

This prospective study evaluated whether the AlignRT surface-guided radiotherapy system improves patient positioning accuracy during stereotactic radiosurgery (SRS) for brain metastases compared with standard manual positioning. Twenty adults scheduled for single-fraction SRS were positioned twice before treatment. Participants were first positioned using the standard manual method with delta couch shift and were then positioned automatically using the AlignRT system. After each positioning method, a partial cone-beam computed tomography (CBCT) scan was performed to measure residual setup deviations in three translational and three rotational directions. The primary objective was to compare the average setup deviations between the two positioning methods and determine whether AlignRT provided more accurate patient positioning. The additional positioning and imaging procedure prolonged the treatment visit by up to 15 minutes and involved a low additional imaging dose.

Detailed description

This was a prospective, single-group clinical study conducted at the Institute of Oncology Ljubljana. The study included adult patients with brain metastases who were scheduled to receive single-fraction stereotactic radiosurgery using the TrueBeam STx linear accelerator. Each participant underwent two positioning procedures before treatment. Standard manual positioning was performed using the delta couch shift function, followed by partial CBCT verification. The participant was then positioned automatically using the AlignRT surface-guided radiotherapy system, followed by a second partial CBCT verification. Residual positioning deviations were recorded in three translational directions (vertical, longitudinal, and lateral) and three rotational directions (rotation, pitch, and roll). The average deviations obtained after manual positioning were compared with those obtained after AlignRT-guided positioning. Additional analyses considered participant age and sex. Positioning data were obtained from the ARIA information system and analyzed using Microsoft Excel and IBM SPSS. A total of 20 participants completed the study. No additional follow-up was required after completion of the positioning measurements.

Interventions

OTHERManual Patient Positioning

Participants were manually positioned from the initial setup position to the treatment isocenter using the delta couch shift function. A partial cone-beam computed tomography scan was then performed to measure residual setup deviations in three translational and three rotational directions.

OTHERAlignRT-Guided Patient Positioning

Participants were automatically positioned at the treatment isocenter using the AlignRT surface-guided radiotherapy system. A partial cone-beam computed tomography scan was then performed to measure residual setup deviations in three translational and three rotational directions.

Sponsors

Institute of Oncology Ljubljana
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

All participants underwent standard manual positioning followed by AlignRT-guided positioning. A partial CBCT verification was performed after each positioning method.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adults aged 18 years or older * Patients with brain metastases eligible for single-fraction stereotactic radiosurgery * Treatment performed using the TrueBeam STx linear accelerator * Able and willing to provide written informed consent.

Exclusion criteria

* Patients younger than 18 years * Patients receiving fractionated stereotactic radiotherapy * Treatment performed using a linear accelerator other than TrueBeam STx.

Design outcomes

Primary

MeasureTime frameDescription
Residual Translational Setup Deviations After Manual and AlignRT-Guided PositioningImmediately after each positioning procedure and before stereotactic radiosurgery, during the same treatment visit.Residual setup deviations measured by partial cone-beam computed tomography in the vertical, longitudinal, and lateral directions, expressed in centimeters. Mean deviations were compared between manual positioning and AlignRT-guided positioning within the same participants.
Residual Rotational Setup Deviations After Manual and AlignRT-Guided PositioningImmediately after each positioning procedure and before stereotactic radiosurgery, during the same treatment visit.Residual setup deviations measured by partial cone-beam computed tomography for rotation, pitch, and roll, expressed in degrees. Mean deviations were compared between manual positioning and AlignRT-guided positioning within the same participants.

Secondary

MeasureTime frameDescription
Difference in Absolute Translational Setup Deviations Between AlignRT-Guided and Manual PositioningImmediately after each positioning procedure and before stereotactic radiosurgery, during the same treatment visit.Within-participant comparison of the absolute residual setup deviations measured in the vertical, longitudinal, and lateral directions after AlignRT-guided positioning and manual positioning. Deviations were expressed in centimeters. Smaller absolute deviations indicate greater positioning accuracy.
Difference in Absolute Rotational Setup Deviations Between AlignRT-Guided and Manual PositioningImmediately after each positioning procedure and before stereotactic radiosurgery, during the same treatment visit.Within-participant comparison of the absolute residual setup deviations measured for rotation, pitch, and roll after AlignRT-guided positioning and manual positioning. Deviations were expressed in degrees. Smaller absolute deviations indicate greater positioning accuracy.

Countries

Slovenia

Contacts

PRINCIPAL_INVESTIGATORKlemen Salmič, MSc

Institute of Oncology Ljubljana

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 22, 2026