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临床试验/NCT01961934
NCT01961934撤回2 期

Carbon-11-Sodium Acetate Positron Emission Tomography/Computed Tomography (PET/CT) Imaging Evaluation in Brain Glioma, Post Therapy Necrosis and Pseudo-progression

Phoenix Molecular Imaging1 个研究点 分布在 1 个国家开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
撤回
试验地点
1
主要终点
Biopsy Correlation

研究概览

简要总结

This study will investigate how well Carbon Acetate PET/CT imaging helps to correctly identify recurrent tumor versus post treatment effects (radionecrosis) in patients with previously treated high grade brain gliomas.

详细描述

The study is designed to investigate the effectiveness of Carbon Acetate PET/CT (AC PET)in terms of its ability to distinguish between radionecrosis/pseudo-progression and viable tumor in patients previously treated with surgery and radiation for high grade glioma brain tumors.

Eligible patients with biopsy proven high grade gliomas (WHO grades 3 and 4) status-post prior cranial irradiation for this tumor; age 18 to 70; ECOG/Zubrod of 0-2, no other contraindications to trial entry, and a post-irradiation cranial MRI or CT demonstrating an enhancing lesion of uncertain etiology (not biopsied) will be treated with at least two weeks of steroidal therapy.

Responders to steroidal therapy will be classified as either pseudo-progression (if asymptomatic) or radionecrosis (if symptomatic). Non-responders (those who do not respond clinically, radiographically, or both) will be referred for an FDG PET/CT and initial AC PET/CT within 3 weeks, and subsequently referred for stereotactic biopsy of their lesion followed by focal laser treatment (in the same operative setting) within 3 weeks of AC PET/CT.

Specific Goals/Questions:

  1. What is the yield (sensitivity, accuracy, positive and negative predictive value) of state-of-the-art PET/CT with C-11 Acetate in detecting recurrent disease versus post treatment effects and pseudo-progression in this patient population?
  2. How does the performance of PET with C-11 Acetate compare with that of PET using F-18 fluorodeoxyglucose (FDG-PET) and with that of MRI?
  3. Evaluate the optimal timing for post injection imaging.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients age 18-70
  • Pathologically confirmed World Health Organization (WHO) grade 3 or 4 glioma
  • ECOG/Zubrod 0-2
  • Prior external beam radiotherapy to 59.4-60 Gray by 1.8-2 Gy fractions
  • Post-radiotherapy contrast-enhanced cranial MRI obtained at least 6 weeks after the completion of external beam radiotherapy shows enhancing anomaly (recurrent/progressive tumor versus pseudo-progression versus radionecrosis)
  • Patient completed at least a two week course of palliative steroid therapy for this enhancing anomaly
  • No prior designated therapy other than steroids for presumed radionecrosis or recurrent tumor
  • Patient with no clinical and/or radiological response to steroid therapy
  • Patient eligible for stereotactic brain biopsy
  • Patient eligible for focal laser therapy

排除标准

  • Patients under the age of 18 years
  • Claustrophobic patients

研究组 & 干预措施

Sodium Acetate C11 PET/CT Imaging

Experimental

干预措施: Sodium Acetate C11 PET/CT Imaging (Drug)

结局指标

主要结局

Biopsy Correlation

时间窗: 3 weeks from AC PET Imaging

AC PET imaging results will be correlated with tissue biopsy results

次要结局

  • SUV (Standardized Uptake Value)(Day 1 - Assess at time of PET imaging)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fabio Almeida MD

Medical Director/PI

Phoenix Molecular Imaging

研究点 (1)

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