Ultrafast MRI Imaging to Exclude Constipation

NCT02658201 | Completed

• 1 other identifier: SCH/12/026
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• Correlation between constipation scores for abdominal radiographs and FIESTA MRI

  Correlation between constipation scores for abdominal radiographs and FIESTA MRI

  Day 1

Secondary Outcomes (2)

• 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

Study Arms (1)

MRI group

OTHER

Ultrafast MRI

Device: MRI

Interventions

MRI DEVICE

Ultrafast MRI to assess constipation

MRI group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sheffield Children's NHS Foundation Trust: lead

Study Sites (1)

Sheffield Children's NHS Foundation Trust

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

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Hughes

  Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2015
• First Posted: January 18, 2016
• Study Start: September 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: July 1, 2017
• Last Updated: October 13, 2017

Record last verified: 2017-07

Locations

GB (1)