Use of AlignRT System During Stereotactic Radiosurgery

NCT07716124 | Completed

• 1 other identifier: ERIDNPVO-0017/2025
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Metastases

Keywords

Stereotactic Radiosurgery; Surface-Guided Radiation Therapy; AlignRT

Outcome Measures

Primary Outcomes (2)

• Residual Translational Setup Deviations After Manual and AlignRT-Guided Positioning

  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.

  Immediately after each positioning procedure and before stereotactic radiosurgery, during the same treatment visit.

• Residual Rotational Setup Deviations After Manual and AlignRT-Guided Positioning

  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.

  Immediately after each positioning procedure and before stereotactic radiosurgery, during the same treatment visit.

Secondary Outcomes (2)

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

  Immediately after each positioning procedure and before stereotactic radiosurgery, during the same treatment visit.

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

  Immediately after each positioning procedure and before stereotactic radiosurgery, during the same treatment visit.

Study Arms (1)

Manual and AlignRT-Guided Positioning

EXPERIMENTAL

Participants underwent standard manual positioning followed by automatic positioning using the AlignRT system before stereotactic radiosurgery. A partial cone-beam computed tomography scan was performed after each positioning method to measure residual translational and rotational setup deviations.

Other: Manual Patient Positioning; Other: AlignRT-Guided Patient Positioning

Interventions

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.

Manual and AlignRT-Guided Positioning

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.

Manual and AlignRT-Guided Positioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Klemen Salmič, MSc

  Institute of Oncology Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 21, 2026
• Study Start: April 1, 2025
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)