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临床试验/NCT02658201
NCT02658201已完成不适用

Use Of Ultrafast MRI Imaging (FIESTA) In Diagnosis Of Suspected Constipation In Haematological Malignancy and Immunocompromised Patients

Sheffield Children's NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2012年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
2
主要终点
Correlation between constipation scores for abdominal radiographs and FIESTA MRI

研究概览

简要总结

In haematological malignancy and in immunocompromised patients, constipation is a common symptom caused by a number of factors during treatment. In current clinical practice, an abdominal radiograph is the first imaging investigation for constipation and non specific abdominal pain to support or exclude the clinical suspicion. Children are more sensitive to radiation induced adverse effects especially in the thyroid gland and bone marrow. Immunocompromised patients are at risk of developing a second malignant neoplasm. MRI is an alternative imaging modality without ionizing radiation. Imaging the peritoneal cavity on abdominal MRI has always been challenging primarily because of bowel motion and a long acquisition time for standard T1 and T2 weighted sequences. Recent development of an ultrafast 2 dimensional FIESTA sequence developed by GE (General Electric) Healthcare based on the balanced steady state free precession (b-SSFP) pulse sequence has several advantages: motion insensitivity ( does not interfere with peristalsis), sharp edge definition and higher contrast when compared with the standard SSFSE pulse sequence. FIESTA is well suited for abdominal imaging as it produces motion- free images, allowing clear delineation of intra-peritoneal and retroperitoneal anatomy and is capable of depicting the vascular anatomy and lymph-adenopathy.There is a wide spectrum of diseases which could cause abdominal pain in our study group with constipation being the most common cause but MRI could potentially detect more serious bowel-related chemotherapy induced complications such as typhlitis, pneumatosis coli, veno-occlusive disease, pancreatitis and intra abdominal abscess, which would not be apparent on abdominal radiograph.

详细描述

In haematological malignancy and in immunocompromised patients, constipation is a common symptom caused by a number of factors during treatment. Chemotherapy and certain analgesic medications are major contributory factors in addition to inadequate fluid intake and reduced mobility during treatment. In current practice, an abdominal radiograph is the first imaging investigation for constipation and non specific abdominal pain to support or exclude the clinical suspicion of constipation. However, there is a skin entrance dose of 1.5 msv from plain film with radiation exposure to gonads. Children are more sensitive to radiation induced adverse effects especially the thyroid gland and bone marrow. Immunocompromised patients are also at risk of developing a second malignant neoplasm. Ultrasound is proven to detect faecal loading in the rectum without ionizing radiation but it is difficult to assess the entire length of colon and it largely depends on the operator's experience. MRI is an alternative imaging modality without ionizing radiation. Imaging the peritoneal cavity on abdominal MRI has traditionally been challenging primarily because of bowel motion and long acquisition time for standard T1 and T2 weighted sequences. The recent development of an ultrafast 2 dimensional FIESTA sequence by GE Healthcare based on the balanced steady state free precession (b-SSFP) pulse sequence has several advantages, including motion insensitivity (does not interfere with peristalsis), sharp edge definition and higher contrast when compared with the standard SSFSE pulse sequence. FIESTA images allow clear delineation of intra-peritoneal and retroperitoneal anatomy and are capable of depicting the vascular anatomy and lymph-adenopathy. There is a wide spectrum of diseases which could cause abdominal pain in our study group with constipation being the most common cause but MRI could potentially detect more serious bowel related chemotherapy induced complications such as typhlitis, pneumatosis coli, veno-occlusive disease, pancreatitis and intra abdominal abscess, which would not be apparent on abdominal radiograph.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Patients with haematological malignancy or immunocompromise under the care of the haematology team and undergoing plain abdominal radiograph for abdominal pain as part of routine clinical care.
  • Patients who can stay still in MRI
  • Patient age between 6 and 18 years.

排除标准

  • Patients who require sedation or general anesthesia.
  • Those with signs of acute abdomen.
  • Claustrophobic patient.
  • Patient/parents who are unable to wait for MRI.

研究组 & 干预措施

MRI group

Other

Ultrafast MRI

干预措施: MRI (Device)

结局指标

主要结局

Correlation between constipation scores for abdominal radiographs and FIESTA MRI

时间窗: Day 1

Correlation between constipation scores for abdominal radiographs and FIESTA MRI

次要结局

  • Inter-rater correlation of constipation scores(Day 1)
  • Observed, clinically relevant, additional findings on MRI compared to abdominal radiographs as assessed by the scoring radiologist at the time of review(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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