Clinical Significance of Liquid Biopsy in Brain Tumor Patients: a 5-ALA Guided Approach
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Protoporphyrin IX (PpIX) Fluorescence Level in Glioblastoma Patients
研究概览
简要总结
Glioblastoma (GBM) is the most common and lethal primary brain tumor. Identifying blood biomarkers that reflect the tumor's status is a major unmet need for optimal clinical management. 5-ALA (5-Aminolevulinic Acid) administration leads to the accumulation of fluorescent Protoporphyrin IX (PpIX) in GBM cells, allowing identification during surgery. This project aims to leverage 5-ALA induced fluorescence to maximize the informational power of plasma liquid biopsy as a tool for diagnosis, post-treatment follow-up, and as a prognostic tool in patients with GBM.
详细描述
This is a prospective observational study. Patients with suspected brain tumors requiring 5-ALA fluorescence-guided surgery will be enrolled. Samples of plasma, serum, and urine will be collected at a minimum of two timepoints: once before 5-ALA administration (baseline, T1) and again 12 hours after administration (T2), when PpIX levels are expected to be highest. All sample collection and processing will occur in low-light conditions to prevent PpIX degradation. Samples will be stored at -80°C. Fluorometric analysis (Perkin Elmer Wallac 1420 Victor2 Microplate Reader) will be performed to measure PpIX fluorescence. Additionally, each patient will undergo a pre-operative MRI as per routine care to measure tumor volume, which will be correlated with fluorescence data.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Inclusion Criteria (Glioblastoma Patients):
- •Patient aged 18 years or older
- •Diagnosis of supratentorial glioblastoma at its first occurrence (Grade 4, WHO 2021), confirmed through histological analysis, in a brain area that is accessible for surgical removal.
- •Ability of the patient to give informed consent.
- •Suitability for surgery with fluorescence guidance using 5-ALA.
- •Inclusion Criteria (Other Brain Tumors):
- •Patient aged 18 years or older
- •Ability of the patient to give informed consent.
- •Suitability for surgery with fluorescence guidance using 5-ALA.
排除标准
- •Exclusion Criteria (Glioblastoma Patients):
- •Presence of other systemic tumors.
- •Known allergic sensitivity or contraindications to gadolinium.
- •Contraindications to MRI, such as the presence of non-compatible implanted devices.
- •Significantly compromised renal function (eGFR <30 ml/min/1.73 m²), and/or patients undergoing dialysis.
- •Conditions that contraindicate surgery with fluorescence guidance using 5-ALA.
- •Exclusion Criteria (Other Brain Tumors):
- •Patients suffering from systemic tumors (besides the primary of the brain metastasis).
- •Individuals with known allergies or adverse reactions to gadolinium.
- •Individuals with contraindications for MRI, including those with implants not compatible with the procedure.
- •Individuals with significantly reduced kidney function (eGFR < 30 ml/min/1.73 m²), or those undergoing dialysis.
研究组 & 干预措施
Glioblastoma Patients
Patients aged 18 or older with a first diagnosis of supratentorial glioblastoma (WHO Grade 4), confirmed by histology, who are candidates for 5-ALA fluorescence-guided surgery.
Other Brain Tumor Patients
Patients aged 18 or older with other brain tumors (in differential diagnosis with glioblastoma) who are candidates for 5-ALA fluorescence-guided surgery.
结局指标
主要结局
Protoporphyrin IX (PpIX) Fluorescence Level in Glioblastoma Patients
时间窗: 2 years
PpIX fluorescence level in blood (serum and plasma) and urine at different time-points (pre-administration, 12h post-administration, and potentially other timepoints depending on preliminary observations) in patients with glioblastoma.
次要结局
- Kinetics of 5-ALA-induced Fluorescence(2 years)
- PpIX Fluorescence Level in Control/Other Brain Tumor Patients(2 years)
- Correlation of Fluorescence with Histopathological Characteristics(2 years)
- Correlation of Fluorescence with Tumor Tissue Fluorescence(2 years)
- Correlation of Fluorescence with MRI Lesion Volumes(2 years)