InveStigAting Bladder fiELd-cycLing imAging (ISABELLA)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 10
- 主要终点
- Identification of bladder tumours by Field-Cycling Imaging (FCI) scan
研究概览
简要总结
The goal of this pilot study is explore the parameters that can be obtained in bladder tumours by Field-Cycling Imaging (FCI) in patients with both muscle-invasive and non-muscle invasive tumours. The main question it aims to answer is if FCI can give more diagnostic information than conventional tests.
Participants will have one FCI scan and the results will be correlated with the results of CT urogram or CT scan.
详细描述
Patients with organ-confined muscle invasive bladder cancer are treated either by removal of their bladder at cystectomy or by organ-preserving treatment, generally following neoadjuvant chemotherapy. In some cases, the neoadjuvant chemotherapy can shrink the tumour so that it is clinically undetectable but there may still be tumour cells present microscopically. This presents a difficulty during planning of radiotherapy treatments, which could then miss the tumour and lead to tumour recurrence.
Field-Cycling Imaging (FCI) is an emerging imaging technology pioneered at the University of Aberdeen. FCI can image human tissues non-invasively over a wide range of magnetic field strengths, directly informing on multi-scale tissue structure from nanometres to micrometres. FCI has already shown significant potential for enhanced diagnosis in a range of diseases, and recent results show several potential biomarkers of cancer in breast, colon, and brain.
FCI has not been used in bladder cancer before. In this proof-of-concept study, we will recruit patients with both muscle-invasive and non-muscle invasive tumours to explore the parameters that can be obtained in bladder tumours by FCI. Results of the FCI scans will be correlated with the results of CT urogram or CT scan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Patients attending for flexible cystoscopy found to have a tumour of at least 3 cm in diameter (muscle-invasive or non-muscle invasive)
- •Participants must be aged 18 and above
- •Participants who meet the safety criteria for undergoing an MRI scan
- •Participants who are able to fit inside the scanner
- •Participants must be able to give fully informed consent
- •Participants must be mobile enough to be positioned onto the FCI scanner couch
排除标准
- •Patients with total hip replacement
- •MRI-incompatible conditions, as detected in the MRI safety screening sheet
- •Participants under 18 years old
- •Participants who are unable to communicate in English
- •Participants who are unable to give fully informed consent
- •Women who are pregnant
- •Restrictions to mobility that would prevent the correct positioning in the scanner
- •Participants who suffer from claustrophobia
结局指标
主要结局
Identification of bladder tumours by Field-Cycling Imaging (FCI) scan
时间窗: At baseline
Validation of FCI T1 dispersion profiles as a non-invasive technology able to detect bladder tumours.
次要结局
- Differentiation of bladder tumours assessed by Field-Cycling Imaging (FCI) T1 dispersion profiles(At baseline)