MRI Study With Ferumoxytol in Assessing Early Response in Patients With Glioblastoma Multiforme Receiving Temozolomide and Radiation Therapy
Early Assessment of Tumor Response to Therapy Using Ferumoxytol (Code 7228) as an MR Contrast Agent in Patients With Glioblastoma Multiforme (MedDRA Code 10018337)
調査の概要
状態
条件
詳細な説明
PRIMARY OBJECTIVES:
I. To characterize glioblastoma multiforme (GBM) tumor vascular properties using ferumoxytol (ferumoxytol non-stoichiometric magnetite) and compare to those obtained using gadolinium (Gd) based MRI contrast agent.
II. To characterize vascular changes in GBM tumors associated with standard radio/chemotherapy.
SECONDARY OBJECTIVES:
I. Cerebral blood flow (CBF), mean transit time (MTT), and time-to-peak (TTP) perfusion parameters will be measured for each contrast agent and evaluated in post-hoc analysis.
II. To obtain qualitative assessment of tumor vascularity using time-of-flight (TOF) magnetic resonance (MR) angiography techniques.
III. To characterize changes in the apparent diffusion coefficient (ADC) of tumor water associated with standard radio/chemotherapy in GBM.
OUTLINE:
Patients receive gadolinium intravenously (IV) on day 1 and ferumoxytol non-stoichiometric magnetite IV on day 2 then undergo dynamic susceptibility contrast enhanced (DSC) MRI, and dynamic contrast enhanced (DCE) MRI, diffusion-weighted imaging (DWI) (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose). Ferumoxytol non-stoichiometric magnetite administration continues in the absence of unacceptable toxicity. Patients also receive temozolomide and undergo radiation therapy per standard of care.
After completion of ferumoxytol non-stoichiometric magnetite administration, patients are followed up for 4-6 weeks and then periodically until the resolution or stabilization of unacceptable toxicities.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Oregon
-
Portland、Oregon、アメリカ、97239
- OHSU Knight Cancer Institute
-
-
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:
- Patients must have radiologically and histologically confirmed diagnosis of glioblastoma multiforme
- Patients must have measurable disease, defined as evident tumors with gadolinium enhancement on MRI that is measurable in at least one diameter and visible on both axial and sagittal or coronal views
- Life expectancy of greater than 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 50%)
- Patients scheduled for standard therapy (6 weeks radiation therapy (RT) ~ 60 Gy, plus temozolomide 75 mg/m^2 during 6 week [w] RT, and followed routine monthly temozolomide therapy)
- Patients must be on a stable or decreasing dose (up to 8 mg daily) of dexamethasone throughout the study
- After entry into the study, patients are expected to be followed for at least 1 month after the last infusion of ferumoxytol
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to understand and the willingness to sign a written informed consent document; all patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
Exclusion Criteria:
- Patients who have had chemotherapy or radiotherapy
- Patients may not be receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ferumoxytol: parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations (Ferumoxytol Investigator's Drug Brochure, 2005); patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion
- Patients with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible
- Patients who require monitored anesthesia for MRI scanning
- Patients with history of hemochromatosis or iron overload
- Patients with renal insufficiency (glomerular filtration rate (GFR) < 50)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ferumoxytol
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
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：診断
- 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 |
|---|---|
|
実験的：Ferumoxytol
Patients receive ferumoxytol non-stoichiometric magnetite IV on day 2 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).
Ferumoxytol non-stoichiometric magnetite administration continues in the absence of unacceptable toxicity.
|
与えられた IV
他の名前：
Undergo DCE MRI
他の名前：
Undergo DSC MRI
他の名前：
Undergo DWI
他の名前：
Undergo TOF MR angiography
他の名前：
|
|
アクティブコンパレータ：Gadoteridol
Patients receive gadoteridol IV on day 1 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).
|
与えられた IV
他の名前：
Undergo DCE MRI
他の名前：
Undergo DSC MRI
他の名前：
Undergo DWI
他の名前：
Undergo TOF MR angiography
他の名前：
|
|
アクティブコンパレータ：Gadoteridol Leakage Corrected
Patients receive gadoteridol IV on day 1 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).
|
与えられた IV
他の名前：
Undergo DCE MRI
他の名前：
Undergo DSC MRI
他の名前：
Undergo DWI
他の名前：
Undergo TOF MR angiography
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 |
|---|---|---|
|
Mean Cerebral Blood Volume (CBV)
時間枠：At radiographical progression (between 6 and 12 weeks post first dose of chemoradiation)
|
Radiographical progression is determined based on RANO criteria.
|
At radiographical progression (between 6 and 12 weeks post first dose of chemoradiation)
|
|
Tumor Progression on Conventional MR
時間枠：Anytime between baseline and 12 weeks post treatment initiation: average 6 weeks post treatment initiation.
|
Tumor progression was assessed by RANO criteria (Wen, 2010).
|
Anytime between baseline and 12 weeks post treatment initiation: average 6 weeks post treatment initiation.
|
協力者と研究者
捜査官
- 主任研究者：Edward Neuwelt、OHSU Knight Cancer Institute
研究記録日
主要日程の研究
研究開始
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
- IRB00002753
- P30CA069533 (米国 NIH グラント/契約)
- 2753 (OHSU Knight Cancer Institute)
- 813
- NCI-2015-00224 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- SOL-06062-LX
- NCI-2015-00204
- 8097
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。