A Pilot Interventional Study to Determine the Diagnostic Utility of the Ferumoxytol MRI Tracking Scan in Patients with Glioblastoma Undergoing Oncology Treatment
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
This study investigated using ferumoxytol for brain tumour imaging and tested ferumoxytol imaging properties compared to the standard agent used, and safety associated with ferumoxytol use. Twenty-four hours after ferumoxytol infusion provided the best brain tumour imaging compared to 18 and 30 hours. Five participants had tumours that showed altered imaging with ferumoxytol compared to gadolinium. Four of these participants had additional regions of enhancement with ferumoxyol. No adverse effects were found. None of the study participants reported any discomfort (pain (other than that associated with the needle insertion,) swelling, tightness, or burning sensation) during or after the infusion. Limitations: this is a pilot study and a main study is required to test wider aspects of using ferumoxyol for brain imaging in New Zealand.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 85 Years（—）
- 性别
- All
入选标准
- •1.Patients with an imaging diagnosis of primary glioblastoma
- •2.No chemotherapy or other treatments (such as steroids) have been administered to the patients between the rime of the baseline diagnostic scan and the ferumoxytol infusion.
排除标准
- •1.Patients who are younger than 18 years old.
- •2.Patients who are pregnant or breast feeding.
- •3.Patients who have known allergy to iron preparation or other medication allergy.
- •4.Patients who have haemochromatosis or known clinically significant liver function abnormality.
- •5.The initial diagnostic MRI demonstrates intracranial haemorrhage, calcification or other susceptibility blooming artifacts.