NCT03781284

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

Completed NA Last updated 19 December 2018

What this trial tests

NA trial testing [18F]-FDG PET/MRI in Ulcerative Colitis in 53 participants. Completed in 31 October 2018.

Timeline

1 January 2016

Primary endpoint
31 October 2018

31 October 2018

Quick facts

Lead sponsor	Universität Duisburg-Essen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	53
Start date	1 January 2016
Primary completion	31 October 2018
Estimated completion	31 October 2018

Drugs / interventions tested

• [18F]-FDG PET/MRI
• Colonoscopy

Conditions studied

• Ulcerative Colitis — all drugs for Ulcerative Colitis →

Sponsor

Universität Duisburg-Essen — full company profile →

Who can join

18 and older, any sex, with Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. ¹⁸F-FDG PET-MR enterography in predicting histological active disease using the Nancy index in ulcerative colitis: a randomized controlled trial.
   Li Y, Schaarschmidt B, Umutlu L, Forsting M, et al · · 2020 · cited 12× · PMID 31650217 · DOI 10.1007/s00259-019-04535-w
2. Comparison of ¹⁸F-FDG PET-MR and fecal biomarkers in the assessment of disease activity in patients with ulcerative colitis.
   Li Y, Khamou M, Schaarschmidt BM, Umutlu L, et al · · 2020 · cited 9× · PMID 32579403 · DOI 10.1259/bjr.20200167
3. Diagnostic Performance of Simultaneous [¹⁸F]-FDG PET/MR for Assessing Endoscopically Active Inflammation in Patients with Ulcerative Colitis: A Prospective Study.
   Langhorst J, Umutlu L, Schaarschmidt BM, Grueneisen J, et al · · 2020 · cited 6× · PMID 32752196 · DOI 10.3390/jcm9082474