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

Positron Emission Tomography With 18F-fluorodeoxyglucose Combined With MRI for Monitoring Inflammatory Activity in Patients With Ulcerative Colitis

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Diagnostic test: [18F]-FDG PET/MRI; Diagnostic test: Colonoscopy

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PET/MRI with bowel purgation	Diagnostic test: [18F]-FDG PET/MRI; Diagnostic test: Colonoscopy
Experimental: PET/MRI without bowel purgation	Diagnostic test: [18F]-FDG PET/MRI; Diagnostic test: Colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of PET/MRI with and without bowel purgation in percent	Overall segment-based sensitivity using ileocolonoscopy as reference standard will be calculated for PET/MRI with and without bowel purgation	24 hours
Specificity of PET/MRI with and without bowel purgation in percent	Overall segment-based specificity using ileocolonoscopy as reference standard will be calculated for PET/MRI with and without bowel purgation	24 hours
Negative predictive value of PET/MRI with and without bowel purgation in percent	Overall segment-based negative predictive value using ileocolonoscopy as reference standard will be calculated for PET/MRI with and without bowel purgation	24 hours
Positive predictive value of PET/MRI with and without bowel purgation in percent	Overall segment-based positive predictive value using ileocolonoscopy as reference standard will be calculated for PET/MRI with and without bowel purgation	24 hours
Optimized cut-offs	Optimized cut-offs for PET for each bowel segment using ileocolonoscopy as reference standard for each colon segment will be calculated	24 hours
Patient acceptance	18F-FDG PET/MRI without bowel cleansing shows higher patient acceptance than conventional colonoscopy	24 hours
Description of extraintestinal findings	Extraintestinal findings will be assessed by evaluating PET/MRI images	24 hours
The Boston Bowel Preparation Scale	Bowel Preparation Quality will be assessed for both patient groups	24 hours

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen
• Collaborators: Crohn's and Colitis Foundation

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): October 31, 2018
• Study Completion (Actual): October 31, 2018

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 18, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Diagnosis; [18F]-FDG PET/MR enterography
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 360668

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No