PET Combined With MRI for Monitoring Inflammatory Activity in Patients With Ulcerative Colitis
Primary Purpose
Ulcerative Colitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
[18F]-FDG PET/MRI
Colonoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Ulcerative Colitis focused on measuring [18F]-FDG PET/MR enterography, Diagnosis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
PET/MRI with bowel purgation
PET/MRI without bowel purgation
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
Optimized cut-offs
Optimized cut-offs for PET for each bowel segment using ileocolonoscopy as reference standard for each colon segment will be calculated
Patient acceptance
18F-FDG PET/MRI without bowel cleansing shows higher patient acceptance than conventional colonoscopy
Description of extraintestinal findings
Extraintestinal findings will be assessed by evaluating PET/MRI images
The Boston Bowel Preparation Scale
Bowel Preparation Quality will be assessed for both patient groups
Full Information
NCT ID
NCT03781284
First Posted
July 17, 2018
Last Updated
December 18, 2018
Sponsor
Universität Duisburg-Essen
Collaborators
Crohn's and Colitis Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03781284
Brief Title
PET Combined With MRI for Monitoring Inflammatory Activity in Patients With Ulcerative Colitis
Official Title
Positron Emission Tomography With 18F-fluorodeoxyglucose Combined With MRI for Monitoring Inflammatory Activity in Patients With Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen
Collaborators
Crohn's and Colitis Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
[18F]-FDG PET/MR enterography, Diagnosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PET/MRI with bowel purgation
Arm Type
Experimental
Arm Title
PET/MRI without bowel purgation
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
[18F]-FDG PET/MRI
Intervention Type
Diagnostic Test
Intervention Name(s)
Colonoscopy
Primary Outcome Measure Information:
Title
Diagnostic accuracy of PET/MRI with and without bowel purgation
Description
Overall segment-based diagnostic accuracy using ileocolonoscopy as reference standard will be calculated for PET/MRI with and without bowel purgation
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Sensitivity of PET/MRI with and without bowel purgation in percent
Description
Overall segment-based sensitivity using ileocolonoscopy as reference standard will be calculated for PET/MRI with and without bowel purgation
Time Frame
24 hours
Title
Specificity of PET/MRI with and without bowel purgation in percent
Description
Overall segment-based specificity using ileocolonoscopy as reference standard will be calculated for PET/MRI with and without bowel purgation
Time Frame
24 hours
Title
Negative predictive value of PET/MRI with and without bowel purgation in percent
Description
Overall segment-based negative predictive value using ileocolonoscopy as reference standard will be calculated for PET/MRI with and without bowel purgation
Time Frame
24 hours
Title
Positive predictive value of PET/MRI with and without bowel purgation in percent
Description
Overall segment-based positive predictive value using ileocolonoscopy as reference standard will be calculated for PET/MRI with and without bowel purgation
Time Frame
24 hours
Title
Optimized cut-offs
Description
Optimized cut-offs for PET for each bowel segment using ileocolonoscopy as reference standard for each colon segment will be calculated
Time Frame
24 hours
Title
Patient acceptance
Description
18F-FDG PET/MRI without bowel cleansing shows higher patient acceptance than conventional colonoscopy
Time Frame
24 hours
Title
Description of extraintestinal findings
Description
Extraintestinal findings will be assessed by evaluating PET/MRI images
Time Frame
24 hours
Title
The Boston Bowel Preparation Scale
Description
Bowel Preparation Quality will be assessed for both patient groups
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32579403
Citation
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.
Results Reference
derived
PubMed Identifier
31650217
Citation
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.
Results Reference
derived
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PET Combined With MRI for Monitoring Inflammatory Activity in Patients With Ulcerative Colitis
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