Ultrafast MRI Imaging to Exclude Constipation (FIESTA)
Primary Purpose
Constipation
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
MRI
Sponsored by

About this trial
This is an interventional treatment trial for Constipation
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients who require sedation or general anesthesia.
- Those with signs of acute abdomen.
- Claustrophobic patient.
- Patient/parents who are unable to wait for MRI.
Sites / Locations
- Sheffield Children's NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MRI group
Arm Description
Ultrafast MRI
Outcomes
Primary Outcome Measures
Correlation between constipation scores for abdominal radiographs and FIESTA MRI
Correlation between constipation scores for abdominal radiographs and FIESTA MRI
Secondary Outcome Measures
Inter-rater correlation of constipation scores
Inter-rater correlation of constipation scores
Observed, clinically relevant, additional findings on MRI compared to abdominal radiographs as assessed by the scoring radiologist at the time of review
Observed, clinically relevant, additional findings on MRI compared to abdominal radiographs as assessed by the scoring radiologist at the time of review
Full Information
NCT ID
NCT02658201
First Posted
April 23, 2015
Last Updated
October 12, 2017
Sponsor
Sheffield Children's NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT02658201
Brief Title
Ultrafast MRI Imaging to Exclude Constipation
Acronym
FIESTA
Official Title
Use Of Ultrafast MRI Imaging (FIESTA) In Diagnosis Of Suspected Constipation In Haematological Malignancy and Immunocompromised Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Children's NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRI group
Arm Type
Other
Arm Description
Ultrafast MRI
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Description
Ultrafast MRI to assess constipation
Primary Outcome Measure Information:
Title
Correlation between constipation scores for abdominal radiographs and FIESTA MRI
Description
Correlation between constipation scores for abdominal radiographs and FIESTA MRI
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Inter-rater correlation of constipation scores
Description
Inter-rater correlation of constipation scores
Time Frame
Day 1
Title
Observed, clinically relevant, additional findings on MRI compared to abdominal radiographs as assessed by the scoring radiologist at the time of review
Description
Observed, clinically relevant, additional findings on MRI compared to abdominal radiographs as assessed by the scoring radiologist at the time of review
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Patients who require sedation or general anesthesia.
Those with signs of acute abdomen.
Claustrophobic patient.
Patient/parents who are unable to wait for MRI.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Hughes
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheffield Children's NHS Foundation Trust
City
Sheffield
State/Province
Sheffield (South Yorkshire district)
ZIP/Postal Code
S10 2TH
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Ultrafast MRI Imaging to Exclude Constipation
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