Use of AlignRT System During Stereotactic Radiosurgery
2026년 7월 15일 업데이트: Institute of Oncology Ljubljana
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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
20
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ljubljana, 슬로베니아, 1000
- Institute of Oncology Ljubljana
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Manual and AlignRT-Guided Positioning
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.
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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.
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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Residual Translational Setup Deviations After Manual and AlignRT-Guided Positioning
기간: Immediately after each positioning procedure and before stereotactic radiosurgery, during the same treatment visit.
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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.
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Immediately after each positioning procedure and before stereotactic radiosurgery, during the same treatment visit.
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Residual Rotational Setup Deviations After Manual and AlignRT-Guided Positioning
기간: Immediately after each positioning procedure and before stereotactic radiosurgery, during the same treatment visit.
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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.
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Immediately after each positioning procedure and before stereotactic radiosurgery, during the same treatment visit.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Difference in Absolute Translational Setup Deviations Between AlignRT-Guided and Manual Positioning
기간: Immediately after each positioning procedure and before stereotactic radiosurgery, during the same treatment visit.
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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.
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Immediately after each positioning procedure and before stereotactic radiosurgery, during the same treatment visit.
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Difference in Absolute Rotational Setup Deviations Between AlignRT-Guided and Manual Positioning
기간: Immediately after each positioning procedure and before stereotactic radiosurgery, during the same treatment visit.
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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.
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Immediately after each positioning procedure and before stereotactic radiosurgery, during the same treatment visit.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Klemen Salmič, MSc, Institute of Oncology Ljubljana
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 4월 1일
기본 완료 (실제)
2025년 8월 31일
연구 완료 (실제)
2025년 8월 31일
연구 등록 날짜
최초 제출
2026년 7월 15일
QC 기준을 충족하는 최초 제출
2026년 7월 15일
처음 게시됨 (실제)
2026년 7월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 21일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 15일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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