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临床试验/NCT06499831
NCT06499831进行中(未招募)不适用

18F-FET-PET/MRI Versus Standard MRI Alone for Stereotactic RadioTherapy Planning for High Grade Brain Gliomas: A Pilot Study

Sunnybrook Health Sciences Centre2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
30
试验地点
2
主要终点
Observe recurrence/evaluate diagnostic performance of PET-FET/MRI vs MRI alone

研究概览

简要总结

Amino acid PET imaging for brain gliomas is gaining acceptance for the diagnosis and monitoring of disease. This is commonly performed in Europe. There is an opportunity to develop this tracer for use in Ontario, specifically for accurate delineation of disease for therapy planning and for prediction of disease recurrence, which is difficult with conventional imaging and clinical assessment techniques. The goals of this project are to develop this tracer in our local setting for use in our patients, provide evidence in the Ontario setting of its utility in addressing these unmet needs, and provide pilot evidence for future clinical trials.

Gliomas are primary malignancies of the brain. The most aggressive and common form is glioblastoma multiforme (GBM), which accounts for more than 60% of all primary brain malignancies . The standard of care for patients with glioblastoma is maximally safe resection of the enhancing tumor regions and the necrotic core followed by radiotherapy with concurrent temozolomide. MRI is widely accepted as the method of choice for treatment planning and for following these patients to predict and to detect recurrent disease.

High grade gliomas represent the most common primary brain malignancy and prognosis remains poor. The most common subtype is glioblastoma which has a 5-year survival rate of approximately 5% . Despite advances in MRI techniques, prediction and diagnosis of treatment failure remains a challenge. The result is frequent imaging mixed with uncertainty regarding the presence of viable tumor versus post-treatment effects. Furthermore, follow-up of these patients represents a high cost to the health system while symptom or disease control remains limited. A more accurate means identifying viable tumor is needed to guide management, reduce costs, and ultimately to improve patient survival and quality of life.

0-(2-18F-Fluoroethyl)-L-Tyrosine positron emission tomography (FET) is an amino acid agent derived from tyrosine that is able to cross the blood brain barrier. It has been studied primarily in diagnosis and detection of tumor recurrence in glioblastomas with emerging evidence for its use in brain metastases. Compared to conventional MRI, FET-PET has been shown to delineate geographically distinct tumor volume in newly diagnosed GBM suggesting the complementarity of the two modalities.

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

盲法说明

The radiation oncologist is blinded to result from FET-FET/MRI while planning on standard fo care MRI.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • >= 18 years of age
  • High grade brain glioma (Grade 3 and 4)
  • No prior radiation or systemic treatment for high grade glioma
  • Planned to undergo radiation therapy with the following regimens:
  • Grade 3: 54-60 Gy over 30 fractions with temozolomide
  • Grade 3: 40Gy over 15 fractions with temozolomide
  • Grade 4: 60 Gy over 30 fractions, with or without temozolomide o Grade 4: 40 Gy over 15 fractions, with or without temozolomide
  • Able to tolerate PET/MRI scan with intravenous contrast
  • Willing to provide informed consent.

排除标准

  • MRI contraindication
  • Creatinine clearance < 30mL/min
  • Inability to lie still for 40 minutes
  • Gadolinium allergy
  • Prior PET imaging
  • Positive pregnancy test
  • Breastfeeding
  • Patient unable to follow the protocol for any reason

结局指标

主要结局

Observe recurrence/evaluate diagnostic performance of PET-FET/MRI vs MRI alone

时间窗: 12 Months

To estimate the rate of change in management due to 18F-FET-PET/MRI when used in addition to standard of care MRI.

次要结局

  • Evaluate tumor volume changes(12 Months)
  • Analysis of PET Data(12 Months)
  • Evaluate recurrence(12 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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