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Completed

NCT Number: NCT02658201

Ultrafast MRI Imaging to Exclude Constipation

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.

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheffield Children's NHS Foundation Trust

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRI

Device

Ultrafast MRI to assess constipation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sheffield Children's NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: FIESTA

Important dates

Study start
2012
Primary completion
2014
Study completion
2017
First posted
Jan 18, 2016
Registry last updated
Oct 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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