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Completed

NCT Number: NCT07716124

Use of AlignRT System During Stereotactic Radiosurgery

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.

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Key information

Conditions

Brain Metastases Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Manual Patient Positioning

Other

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.

AlignRT-Guided Patient Positioning

Other

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.

Primary outcomes

  1. Residual Translational Setup Deviations After Manual and AlignRT-Guided Positioning

    Time frame: Immediately 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.

  2. Residual Rotational Setup Deviations After Manual and AlignRT-Guided Positioning

    Time frame: Immediately 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 outcomes

  1. Difference in Absolute Translational Setup Deviations Between AlignRT-Guided and Manual Positioning

    Time frame: Immediately 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.

  2. Difference in Absolute Rotational Setup Deviations Between AlignRT-Guided and Manual Positioning

    Time frame: Immediately 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.

Sponsors and collaborators

Lead sponsor

Institute of Oncology Ljubljana

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 21, 2026
Registry last updated
Jul 21, 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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