Brain MetastasesNCT07716124
Use of AlignRT System During Stereotactic Radiosurgery
A study testing Manual Patient Positioning and AlignRT-Guided Patient Positioning in people with Brain Metastases, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases
- What is being tested?
- Manual Patient Positioning and AlignRT-Guided Patient Positioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Apr 2025to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients younger than 18 years
- Patients receiving fractionated stereotactic radiotherapy
- Treatment performed using a linear accelerator other than TrueBeam STx.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Brain Metastases
- Being tested
- Manual Patient Positioning, AlignRT-Guided Patient Positioning
- Keywords
- Stereotactic Radiosurgery, Surface-Guided Radiation Therapy, AlignRT
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Patient PositioningOther
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 PositioningOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Manual Patient Positioning; Other: AlignRT-Guided Patient Positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: Immediately after each positioning procedure and before stereotactic radiosurgery, during the same treatment visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Apr 2025
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants underwent standard manual positioning followed by AlignRT-guided positioning. A partial CBCT verification was performed after each positioning method.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Klemen Salmič, MSc, Principal investigator, Institute of Oncology Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716124
- Sponsor's protocol ID
- ERIDNPVO-0017/2025
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of AlignRT System During Stereotactic Radiosurgery
- ClinicalTrials.gov ID
- NCT07716124
- Acronym / sponsor ID
- ERIDNPVO-0017/2025
- Conditions
- Brain Metastases
- Keywords
- Stereotactic Radiosurgery, Surface-Guided Radiation Therapy, AlignRT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants underwent standard manual positioning followed by AlignRT-guided positioning. A partial CBCT verification was performed after each positioning method.
| Arm | Type | Receives |
|---|---|---|
| Manual and AlignRT-Guided Positioning | Experimental | Other: Manual Patient Positioning, Other: AlignRT-Guided Patient PositioningParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients younger than 18 years
- Patients receiving fractionated stereotactic radiotherapy
- Treatment performed using a linear accelerator other than TrueBeam STx.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Patient PositioningParticipants 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. | Other | Manual and AlignRT-Guided Positioning |
| AlignRT-Guided Patient PositioningParticipants 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. | Other | Manual and AlignRT-Guided Positioning |
Primary outcome
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.
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.
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Brain Metastases
RecruitingPhase 4
Brain [18F]-FES PET/CT in Patients With Estrogen-Receptor Positive Breast Cancer
Breast Cancer, Brain Metastases
RecruitingObservational study
Dual Energy CT - a Tool for Delineation of Tumor and Organs at Risk in Radiotherapy
Brain Metastases, Bone Metastases
Not yet recruitingObservational study
Evaluating Biomarkers of Cognitive Dysfunction in Patients With Cancer
Brain Tumor Adult, Brain Metastases From Solid Tumors
RecruitingPhase 2
Tarlatamab for SCLC Brain Metastases
Small Cell Lung Cancer, Brain Metastases, Adult
Not yet recruitingPhase 2
The METAMAX Study: MT027 Allogeneic CAR-T for Brain Metastases From Advanced Solid Tumors
Brain Metastases From Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klemen Salmič, MSc principal investigator
Institute of Oncology Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Patient Positioning and AlignRT-Guided Patient Positioning in people with Brain Metastases, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026; AzTrials last refreshed its copy on 1 Nov 2026.