Ultrafast MRI Imaging to Exclude Constipation (FIESTA)

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

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.

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Device: MRI

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Sheffield (South Yorkshire district)
    • Sheffield, Sheffield (South Yorkshire district), United Kingdom, S10 2TH
      • Sheffield Children's NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: MRI group; Ultrafast MRI	Device: MRI; Ultrafast MRI to assess constipation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between constipation scores for abdominal radiographs and FIESTA MRI	Correlation between constipation scores for abdominal radiographs and FIESTA MRI	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter-rater correlation of constipation scores	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	Observed, clinically relevant, additional findings on MRI compared to abdominal radiographs as assessed by the scoring radiologist at the time of review	Day 1

Collaborators and Investigators

• Sponsor: Sheffield Children's NHS Foundation Trust
• Investigators: Principal Investigator: David Hughes, Investigator

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): April 1, 2014
• Study Completion (ACTUAL): July 1, 2017

Study Registration Dates

• First Submitted: April 23, 2015
• First Submitted That Met QC Criteria: January 14, 2016
• First Posted (ESTIMATE): January 18, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 13, 2017
• Last Update Submitted That Met QC Criteria: October 12, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: SCH/12/026