Ultrafast MRI Imaging to Exclude Constipation (FIESTA)

• ClinicalTrials.gov Identifier: NCT02658201
• Recruitment Status: Completed
• First Posted: January 18, 2016
• Last Update Posted: October 13, 2017
• Sponsor: Sheffield Children's NHS Foundation Trust
• Information provided by (Responsible Party): Sheffield Children's NHS Foundation Trust

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.

Condition or disease	Intervention/treatment	Phase
Constipation	Device: MRI	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 11 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Use Of Ultrafast MRI Imaging (FIESTA) In Diagnosis Of Suspected Constipation In Haematological Malignancy and Immunocompromised Patients
• Study Start Date: September 2012
• Actual Primary Completion Date: April 2014
• Actual Study Completion Date: July 2017

Arms and Interventions

Arm	Intervention/treatment
MRI group; Ultrafast MRI	Device: MRI; Ultrafast MRI to assess constipation

Outcome Measures

Primary Outcome Measures :

1. Correlation between constipation scores for abdominal radiographs and FIESTA MRI [ Time Frame: Day 1 ]
   Correlation between constipation scores for abdominal radiographs and FIESTA MRI

Secondary Outcome Measures :

1. Inter-rater correlation of constipation scores [ Time Frame: Day 1 ]
   Inter-rater correlation of constipation scores
2. 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 ]
   Observed, clinically relevant, additional findings on MRI compared to abdominal radiographs as assessed by the scoring radiologist at the time of review

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United Kingdom

Sheffield Children's NHS Foundation Trust

Sheffield, Sheffield (South Yorkshire district), United Kingdom, S10 2TH

Sponsors and Collaborators

Sheffield Children's NHS Foundation Trust

Investigators

• Principal Investigator: David Hughes; Investigator

More Information

• Responsible Party: Sheffield Children's NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT02658201
• Other Study ID Numbers: SCH/12/026
• First Posted: January 18, 2016
• Last Update Posted: October 13, 2017
• Last Verified: July 2017

Additional relevant MeSH terms:

Constipation; Signs and Symptoms, Digestive