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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
Universität Duisburg-Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ulcerative Colitis focused on measuring [18F]-FDG PET/MR enterography, Diagnosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 17, 2018
    Last Updated
    December 18, 2018
    Sponsor
    Universität Duisburg-Essen
    Collaborators
    Crohn's and Colitis Foundation
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    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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