DTI & Tractography in Pediatric Tumor Surgery
Application of Diffusion Tensor Imaging and Tractography in Pediatric Tumor Surgery
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Sandrine DeRibaupierre, MD
- 電話番号：519-685-8107
- メール：sderibau@uwo.ca
研究連絡先のバックアップ
- 名前：Ali Khan, MD
- 電話番号：24280 519-931-5777
- メール：alir@robarts.ca
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：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).
|
|
|
他の：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).
|
BrightMatter™ Plan (BMP): BMP は、外科医が術前に脳神経外科手術を計画できるようにするソフトウェアです。 BMP は、全脳トラクトグラフィーと、解剖学的 MRI および DTI 画像の高精度な融合を自動的に生成します。 BrightMatter™ Bridge (BMB): BMB では、SMI の MRI 専門知識を提供して、DTI 画像を取得するために最適化されたプロトコルが使用されるようにする DTI を含むニューロ イメージングのスムーズなワークフローを確保します。 画像が取得されると、品質管理 (QC) アルゴリズムを使用してリアルタイムで品質が評価されます。 QC により、スキャン時に DTI 画像の品質評価が可能になり、患者がまだそこにいる間に即座に修正できるようになり、患者の再スキャンの必要性が減少します。 BrightMatter™ Guide (BMG): BMG は、術前に BMP で外科医が計画した DTI 情報と軌道を利用し、術中に手術室に持ち込むニューロ ナビゲーション システムです。
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Total volume of tract damage
時間枠：Assess the total volume of tract damage from baseline pre-operative examination through study completion (~ 1 year).
|
Measure # of damaged tracts
|
Assess the total volume of tract damage from baseline pre-operative examination through study completion (~ 1 year).
|
|
Total size of craniotomy (resection zone)
時間枠：Measure the total size of craniotomy from time of incision to end of surgery. (1 measurement/subject).
|
Measure craniotomy size
|
Measure the total size of craniotomy from time of incision to end of surgery. (1 measurement/subject).
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Total time it takes for the surgeon to pre-operatively plan cranial approach.
時間枠：Assessed during start of surgical pre-operative plan through to end of surgical pre-operative plan (1 measurement/subject).
|
Measured in hours
|
Assessed during start of surgical pre-operative plan through to end of surgical pre-operative plan (1 measurement/subject).
|
|
合計 OR 時間
時間枠：外科受診時に評価
|
時間単位で測定
|
外科受診時に評価
|
|
Duration of hospital stay
時間枠：Assessed during surgical visit up to 26 weeks
|
Measured in # of days
|
Assessed during surgical visit up to 26 weeks
|
|
Total cost of surgery
時間枠：Assessed through study completion, an average of 1 year
|
Assessed through study completion, an average of 1 year
|
|
|
Quality of life assessment
時間枠：Assessed during surgical visit up to 26 weeks
|
Measured using a standard questionnaire known as the WHOQOL-BREF questionnaire-World Health Organization Quality of Life Assessment
|
Assessed during surgical visit up to 26 weeks
|
|
Functional testing
時間枠：Assessed during surgical visit up to 26 weeks
|
Measured using a routine functional impairment test for the pediatric population known as the Lansky performance scale
|
Assessed during surgical visit up to 26 weeks
|
|
# deaths and complications with surgery
時間枠：Assessed post-operatively after each surgery. Patient is followed until study completion (~ 1 year).
|
Number of cases
|
Assessed post-operatively after each surgery. Patient is followed until study completion (~ 1 year).
|
協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
BrightMatter™ 製品の臨床試験
-
Andrew ParrentUniversity of Western Ontario, Canada; Synaptive Medicalわからない側頭葉てんかん