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评估 TheraSphere 胶质母细胞瘤 (GBM) 装置在复发性 GBM 患者中的安全性的可行性研究 (FRONTIER)

2026年10月29日 更新者：Boston Scientific Corporation

前沿：评估 TheRaSphere 胶质母细胞瘤 (GBM) 设备在复发性 GBM 患者中的安全性的可行性研究

The FRONTIER Study is a prospective, interventional, single-arm, multi-center, study to assess the safety and technical feasibility of TheraSphere GBM in patients with recurrent GBM.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Glioblastoma (GBM) is a highly aggressive brain cancer with a grave prognosis, resulting in <7% of patients surviving to five years post-diagnosis. External beam radiotherapy (EBRT) is currently a mainstay treatment for GBM; however, the dose delivered is limited by side effects. The targeted radiotherapy of the TheraSphere GBM Y-90 Glass Microsphere System (TheraSphere GBM) has promising potential to provide GBM patients with reduced side effects compared to external beam radiotherapy as well as a more effective treatment for this catastrophic disease.

The TheraSphere GBM device utilized in the FRONTIER trial is an yttrium-90 (Y-90) glass microsphere therapy for selective internal radiation therapy (endovascular radiotherapy) in recurrent GBM patients. The TheraSphere GBM treatment utilizes intra-arterial delivery and takes advantage of blood flow and direct tumor delivery. Treatment can be delivered by specific placement of a catheter close to the tumor through known angiographic techniques currently utilized by neuro-endovascular or interventional radiology physicians. Angiographic evaluation prior to treatment allows identification of tumor feeding arteries and definition of the treatment volume. TheraSphere GBM could achieve a high tumor response rate based on delivery of a tumor absorbed dose that is not currently possible with EBRT.

In consideration of the potential benefit of a more localized, targeted treatment with a reduced side effect profile compared to other treatment options, and the potential impact on patients' quality of life for this devastating disease, this First-in-Human Early Feasibility Study (EFS) of the TheraSphere GBM Y-90 Glass Microsphere System for the treatment of recurrent GBM is being conducted.

研究类型

介入性

注册 (估计的)

36

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35294
        • 撤销
        • University of Alabama Birmingham
    • California
      • San Diego、California、美国、92103
        • 招聘中
        • University of California San Diego
        • 首席研究员：
          • Zachary Berman, MD
        • 接触：
      • San Francisco、California、美国、94143
        • 招聘中
        • University of California San Francisco
        • 首席研究员：
          • Nicholas Butowski, MD
        • 接触：
    • Florida
      • Jacksonville、Florida、美国、32224
        • 招聘中
        • Mayo Jacksonville
        • 首席研究员：
          • Alfredo Quinones-Hinojosa, MD
        • 接触：
    • Illinois
      • Chicago、Illinois、美国、60611
    • Maryland
      • Baltimore、Maryland、美国、21287
        • 撤销
        • Johns Hopkins Interventional Radiology Center
    • Missouri
      • St Louis、Missouri、美国、63130
        • 招聘中
        • Washington University School of Medicine
        • 接触：
        • 首席研究员：
          • Arindam Chatterjee, M.D.
    • New York
      • New York、New York、美国、10075
        • 招聘中
        • Lenox Hill Hospital
        • 接触：
        • 首席研究员：
          • John Boockvar, MD
    • Texas
      • Houston、Texas、美国、77030
        • 招聘中
        • MD Anderson Cancer Center
        • 接触：
        • 首席研究员：
          • Stephen Chen, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Subject is 18 years or older and has signed and dated the trial informed consent form (ICF)

  2. Life expectancy ≥ 12 weeks

  3. Subject is willing and able to comply with the trial testing, procedures, and follow-up schedule

  4. History of a histologically confirmed diagnosis of glioblastoma per 2021 WHO criteria

  5. Have radiographic evidence of tumor progression/recurrence with measurable disease (≥ 1 cm to ≤ 5cm bidirectional diameters) by contrast-enhancement on MRI, according to RANO criteria

  6. Prior surgery and treatment with combination of radiotherapy and chemotherapy ± Tumor Treating Fields (Optune®)

  7. Prior cranial radiation dose < 66 Gy

  8. WHO performance status ≤ 2

  9. The interval since completion of cranial radiotherapy must be > 6 months, unless there is tissue confirmation of tumor recurrence/progression outside the previous radiation treatment field, in which case the interval since completion of cranial radiation must be at least 12 weeks

  10. Interval since last systemic therapy until presumed date of intervention ≥ 1 cycle or ≥ 2 biological half-lives, i.e.

    1. ≥ 4 weeks since last dose of temozolomide
    2. ≥ 6 weeks since last dose of lomustine or other nitrosourea
    3. ≥ 2 weeks since last dose of a small molecule targeted agent (Tyrosine Kinase Inhibitor or similar)
    4. ≥ 6 weeks from last dose of last intravenous bevacizumab infusion, or other antibody-based VEGF therapy

  11. If receiving steroids, patient should be on a stable or decreasing dose equivalent to dexamethasone ≤ 6 mg/d, for at least 7 days prior to registration

  12. Have adequate organ and bone marrow function within 14 days prior to registration, as defined below:

    1. INR ≤ 1.2 (in absence of anticoagulation)
    2. Platelets ≥ 100,000/L
    3. Creatinine ≤1.5 mg/dL
    4. Absolute Neutrophil Count ≥1.5 x 10^9/L
    5. Hemoglobin ≥9.0 g/dL

  13. Have a negative pregnancy test within 14 days prior to registration on study (for FOCBP, female of child-bearing potential)

  14. Subject is a male or non-pregnant female. If female of child-bearing potential, and if sexually active must be using, or agree to use, a medically acceptable method of birth control as confirmed by the investigator

  15. Angiographic Mapping Inclusion Criteria:

    1. Accessible neurovascular anatomy that allows for safe microcatheter placement (up to two locations) to infuse TheraSphere GBM to treat all of the T1 enhancing component of target lesion confirmed by neuro-interventional team.
    2. Total treatment volume is ≤ 150cc as determined by multidisciplinary team.

  16. Additional Inclusion Criteria:

    1. Group A: perfused volume encompasses the non-dominant hemisphere and non-eloquent regions of the brain
    2. Group B: perfused volume encompasses the non-dominant hemisphere and eloquent regions of the brain
    3. Group C: perfused volume encompasses the dominant hemisphere and non-eloquent regions of the brain
    4. Group D: perfused volume encompasses the dominant hemisphere and eloquent regions of the brain

Exclusion Criteria:

  1. Have bilateral gadolinium enhancing disease, tumor located in the posterior fossa, tumor involving critical subcortical structures (thalamus/hypothalamus, midbrain, brainstem, corticospinal tract, internal capsule, cerebral peduncle), tumor approximating or invading the brainstem and/or optic chiasma, leptomeningeal disease, or extracranial metastatic disease

  2. Have received more than 1 course of prior cranial radiotherapy (EBRT)

  3. Have received radiosurgery, brachytherapy, or hypofractionated radiotherapy

  4. Have received more than 2 systemic treatment protocols (lines of treatment), not including maintenance temozolomide

  5. Have received prior intra-arterial cerebral infusion therapy

  6. Have received more than 2 surgical GBM-related procedures

  7. Have received prior thoracic radiation therapy

  8. Are at increased risk of wound dehiscence by the discretion of the investigators (e.g. brain surgery within the last 3 months, poor skin condition, and/or previously infected surgical field or any other condition that is of increased infectious risk in the opinion of the neurosurgeon)

  9. Have uncontrolled epilepsy

  10. Have severe and/or insufficiently controlled intercurrent illness; patients with the following are not eligible:

    1. Hypertension grade 3 or higher without adequate control on medications
    2. Symptomatic or unstable cardiac disease, known to have right-to-left shunts, or severe pulmonary hypertension (pulmonary artery pressure > 90 mmHg)
    3. Pulmonary insufficiency (arterial oxygen pressure (Pa,O2) of < 60 mmHg, or oxygen saturation (Sa,O2) of < 90%) as measured by fingertip pulse oximeter
    4. Ongoing or active bacterial or viral infection requiring systemic treatment (including HIV)
    5. Pneumonitis
    6. Psychiatric illness/social situations that would limit compliance with study requirements
    7. Peripheral Neuropathy ≥ grade 1
    8. Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety, study endpoints or longevity

  11. Are currently pregnant or breast feeding (unless patient agrees to stop breastfeeding)

  12. Patients with a history of an active other malignancy within 1 year prior to registration. NOTE: Exceptions to this requirement include adequately treated non-melanoma skin cancer or lentigo maligna or carcinoma in situ without evidence of disease, or recurrent glioblastoma

  13. Patients with a history of ischemic cerebral disease and/or at risk of cerebral herniation

  14. Medical contraindication to undergo contrast-enhanced magnetic resonance imaging (MRI)

  15. Known history of hypersensitivity reactions to iodinated and/or gadolinium-based contrast

  16. Subject has received any other investigational agents within 4 weeks of treatment, or is currently participating, or plans to participate in, another investigational trial that may confound the results of this trial (unless written approval is received from the Boston Scientific study team)

  17. Angiographic Mapping Exclusion Criteria: Patients with significant vascular disease, significant AV shunting, or anatomic tortuosity on MR/CT Angiogram precluding safe or feasible vascular access

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Treatment Group A

Subjects in which the perfused volume encompasses the non-dominant hemisphere and non-eloquent regions of the brain. The projected radiation absorbed dose to the treatment volume is 40 Gy ±10%.
设备：TheraSphere GBM

Single treatment of TheraSphere GBM device

其他名称：
  • TheraSphere™ GBM Y-90 玻璃微球 (TheraSphere GBM)
实验性的：Treatment Group B

Subjects in which the perfused volume encompasses the non-dominant hemisphere and eloquent regions of the brain. The projected radiation absorbed dose to the treatment volume is 40 Gy ±10%.
设备：TheraSphere GBM

Single treatment of TheraSphere GBM device

其他名称：
  • TheraSphere™ GBM Y-90 玻璃微球 (TheraSphere GBM)
实验性的：Treatment Group C

Subjects in which the perfused volume encompasses the dominant hemisphere and non-eloquent regions of the brain. The projected radiation absorbed dose to the treatment volume is 40 Gy ±10%.
设备：TheraSphere GBM

Single treatment of TheraSphere GBM device

其他名称：
  • TheraSphere™ GBM Y-90 玻璃微球 (TheraSphere GBM)
实验性的：Treatment Group D

Subjects in which the perfused volume encompasses the dominant hemisphere and eloquent regions of the brain. The projected radiation absorbed dose to the treatment volume is 40 Gy ±10%.
设备：TheraSphere GBM

Single treatment of TheraSphere GBM device

其他名称：
  • TheraSphere™ GBM Y-90 玻璃微球 (TheraSphere GBM)

研究衡量的是什么？

主要结果指标

结果测量
大体时间
3-5 级非血液学毒性的数量
大体时间：索引程序后 30 天
索引程序后 30 天
与非靶向栓塞相关的 ≥ 3 级 CNS 毒性的数量
大体时间：索引程序后 30 天
索引程序后 30 天
发生有症状的脑辐射坏死，需要药物或手术干预并经病理学证实
大体时间：索引程序后 30 天
索引程序后 30 天
持续超过 5 天的 4 级中性粒细胞减少事件的数量
大体时间：索引程序后 30 天
索引程序后 30 天
4级发热性中性粒细胞减少症的数量
大体时间：索引程序后 30 天
索引程序后 30 天
4级血小板减少症或3级血小板减少症伴出血的人数
大体时间：索引程序后 30 天
索引程序后 30 天

次要结果测量

结果测量
措施说明
大体时间
任何治疗相关的不良事件和治疗相关的严重不良事件（不包括预定义的限制性毒性）从第一位患者入组到研究完成的发生率。
大体时间：通过索引程序后 6 个月的注册
通过索引程序后 6 个月的注册
从第一位入组患者到研究完成的客观缓解率* (ORR)
大体时间：通过索引程序后 6 个月的注册
通过索引程序后 6 个月的注册
从第一位入组患者到研究完成的无进展生存期* (PFS)
大体时间：通过索引程序后 6 个月的注册
通过索引程序后 6 个月的注册
从第一位入组患者到研究完成的总生存期 (OS)
大体时间：通过索引程序后 6 个月的注册
通过索引程序后 6 个月的注册
Therasphere GBM的技术成功/可行性 - 能够将预计的辐射剂量（+/- 20％）输送到所有接受该设备治疗的患者的灌注体积。从筛查到设备后递送PET-CT/MRI评估。
大体时间：通过设备后交付PET-CT/MRI进行筛查。
通过设备后交付PET-CT/MRI进行筛查。
Change in post-treatment neurological function as assessed by the National Institute of Health Stroke Scale (NIHSS).
大体时间：Enrollment through 6 months post index procedure

The NIHSS is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.
Enrollment through 6 months post index procedure
Change in post-treatment neurological function as assessed by the modified Rankin Scale (mRS).
大体时间：Enrollment through 6 months post index procedure

The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability on a scale from 0 (no symptoms at all) to 6 (death).
Enrollment through 6 months post index procedure

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Boston Scientific Corporation

调查人员

  • 首席研究员：Riad Salem, M.D.、Northwestern University
  • 首席研究员：Roger Stupp, M.D.、Northwestern University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年7月30日

初级完成 (估计的)

2027年1月31日

研究完成 (估计的)

2027年6月30日

研究注册日期

首次提交

2022年3月10日

首先提交符合 QC 标准的

2022年3月29日

首次发布 (实际的)

2022年3月31日

研究记录更新

最后更新发布 (实际的)

2026年10月30日

上次提交的符合 QC 标准的更新

2026年10月29日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • S2478

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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