Fluorescein vs. iMRI in Resection of Malignant High Grade Glioma
Fluorescein vs. Intraoperative MRI in the Resection of Malignant High Grade Glioma
This study plans to learn more about if fluorescein with intraoperative Magnetic Resonance Imaging (MRI) is as good as intraoperative MRI (iMRI) alone in detecting the presence of tumor tissue during surgery.
Both fluorescein and intraoperative MRI have been studied and routinely used to aid the neurosurgeon in distinguishing normal brain from tumor, helping the neurosurgeon to safely resect more tumor tissue during surgery.
This study will enroll patients with malignant high grade glioma who are going to have a surgery to remove their brain tumor.
For half of the patients, fluorescein and intraoperative MRI will be used together during surgery. For half of the patients, only intraoperative MRI will be used during surgery. iMRI is used as final verification of complete, safe resection in both arms.
調査の概要
詳細な説明
Extent of surgical resection of malignant high grade glioma has been established as one of the most important predictors of overall survival and six-month progression free survival. Unfortunately, it is often difficult in surgery to distinguish between tumor and normal brain. Various technologies have been developed to help the surgeon more readily safely increase extent of resection in order to achieve an improved survival after glioblastoma resection. Fluorescein has been used at some institutions for a number of years to improve visualization of high-grade gliomas enabling their better resection. Intraoperative MRI has also been developed with similar intent, allowing the patient to be imaged intraoperatively to determine extent of resection and any need for further resection prior to leaving the operating room. While there is some evidence these technologies improve extent of resection in comparison to historical controls, they have never been tested against each other in any prospective fashion.
Intraoperative MRI has significant cost and significantly increases operative time. Fluorescein is a very inexpensive injectable agent and, if as good at achieving gross total resection as intraoperative MRI, would offer patients similar surgical outcomes with less anesthetic time and cost than intraoperative MRI. This study aims to investigate the value of fluorescein or intraoperative MRI in malignant glioma patients' extent of tumor resection in a prospectively randomized manner.
研究の種類
段階
- 適用できない
連絡先と場所
研究場所
-
-
Colorado
-
Aurora、Colorado、アメリカ、80045
- University of Colorado Anschutz Medical Campus
-
-
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:
- Presents with presumed or pathologically proven enhancing primary or secondary high grade glioma for surgical resection
- Eligible for gross total resection of enhancing component of tumor
- Karnofsy performance status >/= 70%
Exclusion Criteria:
- Presence of multi-focal disease
- Disease that crosses the mid-line
- History of adverse reaction to flourescein
- Known ongoing pregnancy
- Inability to grant consent
- Contraindication to perform iMRI
- Contraindication to flourescein
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：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Arm A
Flourescein plus intraoperative MRI
|
fluorescein and conventional neuro-navigation
conventional neuro-navigation and iMRI
他の名前：
|
|
アクティブコンパレータ：Arm B
intraoperative MRI alone
|
conventional neuro-navigation and iMRI
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 |
|---|---|---|
|
Extent of resection
時間枠：36 hours
|
This outcome will utilize tumor volumetry of residual enhancing tumor after resection.
|
36 hours
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Surgical time difference
時間枠：36 hours
|
This outcome will evaluate the difference in length of surgery time between each arm.
|
36 hours
|
協力者と研究者
捜査官
- 主任研究者：David R Ormond, MD、University of Colorado, Denver
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (実際)
研究の完了 (実際)
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 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 15-1313
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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。