PET Combined With MRI for Monitoring Inflammatory Activity in Patients With Ulcerative Colitis

NCT03781284 | Completed

• 1 other identifier: 360668
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

Brief Summary

Colonoscopy is considered crucial for the diagnosis and quantification of ulcerative colitis (UC). However, there are several drawbacks related to the invasiveness, procedure-related discomfort, risk of bowel perforation (especially in the period of acute inflammation), and relatively poor patient acceptance. Most patients regard the necessary bowel cleansing as burdensome. Feasible, accurate and well accepted non-invasive diagnostic techniques are needed for the determination of inflammatory activity and optimal tailoring of therapy. Hybrid PET/MRI represents an innovative combination of two established, non-invasive diagnostic tools: Magnetic resonance imaging (MRI), allowing for anatomic-functional imaging of the abdomen at high soft tissue contrast and positron emission tomography (PET) utilizing 18F-fluorodeoxyglucose (FDG) a non-invasive tool to monitor glucose metabolism and allowing a detection and quantification of inflammatory processes. Since MRI has limited sensitivity in UC and may be hampered by retained stool, a combination with another imaging modality is very appealing. PET, on the other side provides functional information, yet with limited anatomical landmarks and is relatively unsusceptible to artifacts associated to retained stool. In combination, these modalities might provide a valid alternative for the non-invasive assessment of the inflammatory activity in UC patients without the need for bowel purgation. It will therefore have to be investigated whether fecal material does impede the diagnostic quality of the combination of FDG-PET and MRI. For this purpose, the investigators will include 50 patients with confirmed ulcerative colitis. Dependent on clinical activity of the inflammation, patients will be randomized to undergo PET/MRI enterography either with or without prior bowel purgation followed by a colonoscopy. Inflammatory activity in 7 bowel segments will be analyzed based on PET/MRI with and without bowel purgation with the results of colonoscopy as standard of reference. Patient acceptance of PET/MRI with and without bowel purgation as well as colonoscopy will be compared. PET/MRI with and without bowel cleansing will be compared with regard to diagnostic accuracy as well as for its patients' acceptance in comparison to colonoscopy. The investigators hypothesize that PET/MRI will eventually be highly accurate to detect and monitor inflammatory activity in patients with ulcerative colitis. Additional information about extra-intestinal findings might also change the therapeutic concept. PET/MRI might serve as a non-invasive diagnostic option in patients with UC to quantify inflammatory activity especially when bowel cleansing or colonoscopy is not applicable.

Conditions

Ulcerative Colitis

Keywords

[18F]-FDG PET/MR enterography; Diagnosis

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of PET/MRI with and without bowel purgation

  Overall segment-based diagnostic accuracy using ileocolonoscopy as reference standard will be calculated for PET/MRI with and without bowel purgation

  24 hours

Secondary Outcomes (8)

• Sensitivity of PET/MRI with and without bowel purgation in percent

  24 hours

• Specificity of PET/MRI with and without bowel purgation in percent

  24 hours

• Negative predictive value of PET/MRI with and without bowel purgation in percent

  24 hours

• Positive predictive value of PET/MRI with and without bowel purgation in percent

  24 hours

• Optimized cut-offs

  24 hours

Study Arms (2)

PET/MRI with bowel purgation

EXPERIMENTAL

Diagnostic Test: [18F]-FDG PET/MRI; Diagnostic Test: Colonoscopy

PET/MRI without bowel purgation

EXPERIMENTAL

Diagnostic Test: [18F]-FDG PET/MRI; Diagnostic Test: Colonoscopy

Interventions

[18F]-FDG PET/MRI DIAGNOSTIC_TEST

PET/MRI with bowel purgation; PET/MRI without bowel purgation

Colonoscopy DIAGNOSTIC_TEST

PET/MRI with bowel purgation; PET/MRI without bowel purgation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with confirmed ulcerative colitis verified by the defining symptoms (rectal bleeding, diarrhea), endoscopy and histopathology
• clinically indicated colonoscopy and 18F-FDG PET as either initial assessment or follow- up examination
• patient age ≥ 18 years

You may not qualify if:

• Patients aged \< 18years
• Patients with MRI contraindications, e.g. presence of cardiac pacemaker, implanted cardioverter-defibrillator, neurostimulation systems or with claustrophobia.
• acute renal failure, severe chronic renal failure (calculated glomerular filtration rate \[GFR\] \< 30 ml/min)
• allergy to i.v. gadolinium based contrast agents

Sponsors & Collaborators

• Universität Duisburg-Essen: lead
• Crohn's and Colitis Foundation: collaborator

Related Publications (2)

• Li Y, Khamou M, Schaarschmidt BM, Umutlu L, Forsting M, Demircioglu A, Haubold J, Koch AK, Bruckmann NM, Sawicki LM, Herrmann K, Boone JH, Langhorst J. Comparison of 18F-FDG PET-MR and fecal biomarkers in the assessment of disease activity in patients with ulcerative colitis. Br J Radiol. 2020 Aug;93(1112):20200167. doi: 10.1259/bjr.20200167. Epub 2020 Jun 24.

  PMID: 32579403 DERIVED

• Li Y, Schaarschmidt B, Umutlu L, Forsting M, Demircioglu A, Koch AK, Martin O, Herrmann K, Juette H, Tannapfel A, Langhorst J. 18F-FDG PET-MR enterography in predicting histological active disease using the Nancy index in ulcerative colitis: a randomized controlled trial. Eur J Nucl Med Mol Imaging. 2020 Apr;47(4):768-777. doi: 10.1007/s00259-019-04535-w. Epub 2019 Oct 24.

  PMID: 31650217 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative; Disease

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: December 19, 2018
• Study Start: January 1, 2016
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share