A Phase 2 Comparative Study of 5-Aminolevulinic Acid (5-ALA) and Intraoperative MRI (iMRI) to Enhance Completeness of Resection of Glioblastoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in Volume of Residual Enhancing Tumor, as Determined by Intraoperative Volume MRI at a Single Time Point Without and With Gadolinium, Following Maximal Resection With Use of Aminolevulinic Acid
研究概览
简要总结
The purpose of this study is to investigate the safety and performance of an investigational agent, known as 5-ALA or Gliolan (aminolevulinic acid), that many be useful to a surgeon for visualizing a tumor during surgery. It is also being studied to determine if there are differences in what Gliolan shows a surgeon compared to intraoperative magnetic resonance imaging (MRI)
详细描述
PRIMARY OBJECTIVES:
I. Determine the volume of residual enhancing tumor after a 5-ALA guided resection of a glioblastoma multiforme (GBM).
II. Determine the volume of tissue removed compared to the measured enhancing tumor evaluated on a pre-operative MRI.
SECONDARY OBJECTIVES:
I. Evaluate the time to tumor progression. II. Evaluate the overall survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have a suspected or biopsy proven newly diagnosed GBM, or a recurrent GBM or suspected GBM (in patient with pathologically diagnosed prior World Health Organization [WHO] grade II or III tumor) in a patient undergoing a clinically-indicated surgery.
- •Age >= 18 years of age.
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
- •Life expectancy is not a consideration for protocol entry
- •Patients must have normal organ and marrow function as defined below:
- •Absolute neutrophil count >= 1,500/uL
- •Platelets >= 100,000/uL
- •Total bilirubin within normal institutional limits
- •Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
- •Creatinine within normal institutional limits; OR
- •Creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
- •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 or have a parent or guardian with the ability to understand and the willingness to sign a written informed consent
排除标准
- •Prior therapy is not an exclusion criterion
- •Patients may not be receiving any other investigational agents
- •History of allergic reactions attributed to aminolevulinic acid (ALA)
- •Current treatment with hypericin (or an extract) or other photosensitizing agents
- •Personal or immediate family (parents, siblings, children) history of porphyrias
- •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 ALA
研究组 & 干预措施
Diagnostic (aminolevulinic acid)
Patients receive aminolevulinic acid PO 2-4 hours before surgery.
干预措施: aminolevulinic acid (Drug)
Diagnostic (aminolevulinic acid)
Patients receive aminolevulinic acid PO 2-4 hours before surgery.
干预措施: therapeutic conventional surgery (Procedure)
结局指标
主要结局
Change in Volume of Residual Enhancing Tumor, as Determined by Intraoperative Volume MRI at a Single Time Point Without and With Gadolinium, Following Maximal Resection With Use of Aminolevulinic Acid
时间窗: Day 1
Volume of enhancing tumor (initial and residual) will be determined by use of a softwarebased volumetric analysis method. Intra- and post-op definitions of residual tumor volume need to be adjusted for the presence of T1 hyperintensity due to signal from blood and blood products (as determined on pre-gadolinium volume study).
Comparison Between the Volume of Resected Tissue (Defined as the Volume of the Resection Cavity) and the Pre-operative Enhancing Tumor Volume
时间窗: Up to day 1
Volume of enhancing tumor (initial and residual) will be determined by use of a software-based volumetric analysis method. Intra- and post-op definitions of residual tumor volume need to be adjusted for the presence of T1 hyperintensity due to signal from blood and blood products (as determined on pre-gadolinium volume study).
次要结局
- Time to Disease Progression (TTP), Determined by Review of MRIs Performed Post Operatively as Clinically Indicated, Evaluated With Use of the New International Criteria Proposed by the Response in NeuroOncology (RANO) Committee(From the date of surgery with aminolevulinic acid to the date of progression, assessed up to 1 year)
- Overall Survival, by Periodic Follow up Review of the Patient Charts and by Correlation With the Social Security Death Index(From the date of surgery with aminolevulinic acid to the date of death, assessed up to 4 years)
研究者
Michael Vogelbaum, MD, PhD
Principal Investigator
Case Comprehensive Cancer Center