5-Aminolevulinic Acid (5-ALA) Gliolan®: Usage Increase Proposal for Neurosurgical Procedures in High-Grade Gliomas
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Disease-Free-Survival (PFS)
研究概览
简要总结
The goal of this observational study is to evaluate disease-free survival (DFS) in patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy
详细描述
The investigators are proposing a study that provides descriptive understanding of patients with High-Grade Gliomas in Ecuador. The primary objective of this pilot study is to lay the foundations for the development of a multicenter registry patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy, which will provide high-quality real data and serve as a basis for the application to future projects and elaboration of public policies in the medium and long term.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 to 75 years (in pediatric cases will be included in the Central Nervous System (CNS) tumor board to make decisions on therapeutic management)
- •Patients with radiological suspicion (contrast uptake) of high-grade glioma (Grade III-IV)
- •Patients with high-grade and residual glioma following surgery for gross total resection
- •Patients with recurrent gliomas with reoperation criteria who previously received radiotherapy and chemotherapy
- •Patients for whom at least one postoperative magnetic resonance imaging (MRI) was available (up to 28 days after surgery and strictly before the start of radiotherapy)
- •Progressing, low-grade infiltrative gliomas with one of the following criteria:
- •Anaplastic foci with contrast uptake in MRI
- •Spectroscopy study in anaplastic suspected area with high malignancy criteria
- •Positive choline PET-CT (positron emission tomography / computer tomography)
排除标准
- •Tumors extending across midline
- •Basal ganglia tumor
- •Brainstem tumor
- •Multifocal gliomas
- •Suspected low-grade glioma without anaplastic foci
- •Neuraxial dissemination (ependymoma)
- •Karnofsky grade less than 60%
- •Infants or pregnant women
- •Acute or chronic types of porphyria
- •Non-acceptance of Fluorescence-Guided Surgery
- •Renal insufficiency confirmed by nephrological assessment
- •Hepatic impairment confirmed by gastroenterological assessment
- •Severe heart disease confirmed by cardiological assessment
- •Decompensated diabetes confirmed by endocrinological assessment
- •Known allergy to any contrast agent and/or previous history of anaphylactic shock
- •Hypersensitivity to the active substance or porphyrins
- •Asthma confirmed by pulmonological assessment
- •Pacemaker use
研究组 & 干预措施
Participants with known or suspected High-Grade Gliomas
Patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy
干预措施: 5-Aminolevulinic Acid (5-ALA) Gliolan® (Drug)
Participants with known or suspected High-Grade Gliomas
Patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy
干预措施: Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA) (Procedure)
结局指标
主要结局
Disease-Free-Survival (PFS)
时间窗: 36 months
Disease-Free-Survival calculates the time from treatment until the recurrence of disease or death after undergoing Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA)
次要结局
- Overall survival (OS)(36 months)
- Average length of hospital stay (ALOS)(36 months)
- Quality of life as measured by the Functional Assessment of Cancer Therapy - Brain (FACT-Br) questionnaire(36 months)