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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03781284
• Other study ID #: 360668
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: October 31, 2018

Study information

• Verified date: December 2018
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Diagnostic Test:
• [18F]-FDG PET/MRI

• Colonoscopy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universität Duisburg-Essen	Crohn's & Colitis Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Patient acceptance	18F-FDG PET/MRI without bowel cleansing shows higher patient acceptance than conventional colonoscopy	24 hours
Secondary	Description of extraintestinal findings	Extraintestinal findings will be assessed by evaluating PET/MRI images	24 hours
Secondary	The Boston Bowel Preparation Scale	Bowel Preparation Quality will be assessed for both patient groups	24 hours