Anal Squamous Cell Carcinoma: Investigation of Functional Imaging During chemoRadioTherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Changes on DW MRI during CRT in anal cancer.
研究概览
简要总结
This is a single arm, single centre imaging study which will be offered to all consecutive, eligible patients receiving radical chemoradiation therapy (CRT) for anal cancer within Oxford University Hospitals.
Investigations
- Dynamic contrast enhanced magnetic resonance imaging (DCE MRI)
- Diffusion weighted magnetic resonance imaging (DWI MRI)
- MRI scan designed to measure the T1 or produce T1-weighed images (T1 MRI)
- MRI scan designed to measure the T2* or produce T2*-weighed images (T2* MRI)
- Perfusion computed tomography (pCT)
- Fludeoxyglucose positron emission tomography (FDG PET/CT)
Study Design: Observational
Target Population: Patients undergoing radical CRT for anal cancer in Oxford University Hospitals National Health Service (NHS) Trust.
Duration on study: Patients should be on study for a maximum of 5 months.
Patient care post-trial: Follow up as per local standard.
No. of Study Site(s): Single Centre, United Kingdon (UK)
End of study: Last Patient, last assessment of response. Patients should be on study for a maximum of 5 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Histologically confirmed invasive primary squamous carcinoma of the anus.
- •Patients must be fit and scheduled to receive radical CRT with curative intent.
- •Any stage tumor 2-node 0 (T2N0)
- •Male or female, Age 18 years+.
- •The patient is willing and able to comply with the images and protocol for the duration of the study.
- •Written (signed and dated) informed consent.
排除标准
- •Pregnant or breast-feeding women or women of childbearing potential unless effective methods of contraception are used.
- •Previous pelvic radiotherapy
- •Patients with a pacemaker or any other implanted metal which would preclude MRI scan.
- •Patients with a prosthetic hip.
- •Patients receiving radiotherapy with palliative intent.
- •Active medical or psychological illness that would render the patient unsuitable for the additional imaging proposed in this study, at the discretion of the investigator
- •Additional criteria for optional oxygen breathing procedure:
- •Patients with Chronic Obstructive Pulmonary Disease
- •Any patient not felt to be suitable for supplementary oxygen as considered by an appropriately trained clinician
结局指标
主要结局
Changes on DW MRI during CRT in anal cancer.
时间窗: Fraction 8-10 of CRT (Day 10-12) compared with prior to CRT (Day 1)
The number of patients with a change in ADC values of \<20% between pre-CRT DW MRI and repeat DW MRI following 8-10 fractions of CRT
次要结局
- Correlation of the change in functional images over CRT with outcome of CRT(3 months post CRT)
- Correlation of findings on different functional images.(Both prior to CRT day 1 and fraction 8-10)
- Changes on DCE MRI, Perfusion CT, T2* MRI, FDG PET(Fraction 8-10 of CRT (Day 10-12))
- Correlation of baseline functional images with outcome of CRT(3 months post CRT compared with prior to CRT (Day 1))