DTI & Tractography in Pediatric Tumor Surgery
Application of Diffusion Tensor Imaging and Tractography in Pediatric Tumor Surgery
연구 개요
상세 설명
Brain tumours are the most common form of solid tumours in children which often arise from the cerebellum. Treatment involves a complete resection of the tumour. Although surgical resection may eliminate most of the malignancy, signs of post-neurologic deficit may present as a consequence to the treatment.
One such example is cerebellar mutism syndrome (CMS), a postoperative syndrome typically arising 1 to 2 days after resection of a midline posterior fossa tumor; it consists of diminished speech progressing to mutism, emotional lability, hypotonia, and ataxia. While some of the symptoms recover after a few months, neuropsychological testing shows long term deficits in language (agramatism), executive function and verbal memory.
This study aims to investigate whether the use of Synaptive Medical's BrightMatter™ technology can help neurosurgeons better visualize and plan surgeries by avoiding eloquent fiber tracts in the brain and cerebellum; thus minimizing damage pertaining to neurologic and motor functionality. The use of these products will also be assessed for improved clinical outcomes in pediatric tumor surgery.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Pediatric subjects between the ages of 0-18 years with a brain tumor.
Exclusion Criteria:
- Pediatric subjects with contra-indication to MRI (metal, claustrophobia, etc.)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: Control
Control Group (surgical standard of care): Subjects 18 years and younger diagnosed with a pediatric brain tumor, and who are eligible for surgical treatment will be recruited.
All subjects will have clinical MRI scans that include a diffusion tensor imaging (DTI) protocol.
Surgery will be carried out according to usual standard of care, without the use of processing for DTI tractography.
Additional clinical scanning with the same protocol will be carried out post-operatively at 6 months.
Pre-operative and post-operative quality of life assessments, functional testing and clinical outcome tests will be conducted at this post-operative period (6-months).
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다른: Interventional
Interventional Group (involvement of all BrightMatter™ products): Subjects 18 years and younger diagnosed with a pediatric brain tumor and who are eligible for surgical treatment will be recruited.
All subjects will have clinical MRI scans that include a diffusion tensor imaging (DTI) protocol and will be sent to the interventional technology (BrightMatter Bridge) for quality control.
The QC'ed images will then be sent to a pre-operating planning software (BrightMatter Plan) for planning the surgical approach.
Surgery will be carried out with guidance from the exported plan and the intra-operative neuro-navigation software, BrightMatter Guide, with the use of post-processing DTI tractography.
Additional clinical scanning with the same protocol will be carried out post-operatively at 6 months.
Pre-operative and post-operative quality of life assessments, functional testing and clinical outcome tests will be conducted at this post-operative period (6-months).
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BMP(BrightMatter™ Plan): BMP는 외과 의사가 수술 전 신경외과 계획을 세울 수 있게 해주는 소프트웨어입니다. BMP는 해부 MRI 및 DTI 이미지의 고도로 정확한 융합과 전체 뇌 트랙토그래피를 자동으로 생성합니다. BMB(BrightMatter™ Bridge):BMB는 SMI의 MRI 전문 기술을 제공하여 DTI를 포함한 신경 영상의 원활한 작업 흐름을 보장하여 최적화된 프로토콜을 사용하여 DTI 이미지를 획득하도록 합니다. 이미지가 획득되면 품질 관리(QC) 알고리즘을 사용하여 실시간으로 품질을 평가합니다. QC는 스캔 시 DTI 이미지의 품질 평가를 허용하여 환자가 있는 동안 즉각적인 수정이 가능하고 환자를 다시 스캔할 필요성을 줄입니다. BMG(BrightMatter™ Guide): BMG는 수술 전 BMP에서 의사가 계획한 DTI 정보와 궤적을 활용하지만 수술 중 수술실로 가져오는 신경 탐색 시스템입니다.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Total volume of tract damage
기간: Assess the total volume of tract damage from baseline pre-operative examination through study completion (~ 1 year).
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Measure # of damaged tracts
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Assess the total volume of tract damage from baseline pre-operative examination through study completion (~ 1 year).
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Total size of craniotomy (resection zone)
기간: Measure the total size of craniotomy from time of incision to end of surgery. (1 measurement/subject).
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Measure craniotomy size
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Measure the total size of craniotomy from time of incision to end of surgery. (1 measurement/subject).
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Total time it takes for the surgeon to pre-operatively plan cranial approach.
기간: Assessed during start of surgical pre-operative plan through to end of surgical pre-operative plan (1 measurement/subject).
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Measured in hours
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Assessed during start of surgical pre-operative plan through to end of surgical pre-operative plan (1 measurement/subject).
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총 OR 시간
기간: 외과 방문 중 평가
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시간 단위로 측정
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외과 방문 중 평가
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Duration of hospital stay
기간: Assessed during surgical visit up to 26 weeks
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Measured in # of days
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Assessed during surgical visit up to 26 weeks
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Total cost of surgery
기간: Assessed through study completion, an average of 1 year
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Assessed through study completion, an average of 1 year
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Quality of life assessment
기간: Assessed during surgical visit up to 26 weeks
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Measured using a standard questionnaire known as the WHOQOL-BREF questionnaire-World Health Organization Quality of Life Assessment
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Assessed during surgical visit up to 26 weeks
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Functional testing
기간: Assessed during surgical visit up to 26 weeks
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Measured using a routine functional impairment test for the pediatric population known as the Lansky performance scale
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Assessed during surgical visit up to 26 weeks
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# deaths and complications with surgery
기간: Assessed post-operatively after each surgery. Patient is followed until study completion (~ 1 year).
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Number of cases
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Assessed post-operatively after each surgery. Patient is followed until study completion (~ 1 year).
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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. .
뇌 손상, 만성에 대한 임상 시험
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University of Dublin, Trinity College알려지지 않은Brain Health 은퇴 엘리트 선수
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Hospital Clinic of BarcelonaAstraZeneca완전한CTO(Chronic Total Occlusion)를 위한 PCI(Percutaneous Coronary Intervention)를 받을 예정인 환자스페인
BrightMatter™ 제품에 대한 임상 시험
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Andrew ParrentUniversity of Western Ontario, Canada; Synaptive Medical알려지지 않은
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Centers for Disease Control and Prevention, ChinaBeijing Tiantan Biological Products Co., Ltd.완전한
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United States Army Institute of Surgical Research완전한
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University of Sao PauloFundação de Amparo à Pesquisa do Estado de São Paulo; InCor Heart Institute완전한백혈구 장애 | 전신 염증 반응 증후군(SIRS) | 관상동맥우회술로 인한 합병증