Clinical trial NCT02622139: Multispectral Optoacoustic Tomography (MSOT) for the Evaluation of Disease Activity in Inflammatory Bowel Diseases (IBD)
Official title: Monocentric, Prospective Interventional Study to Assess the Degree of Disease Activity With a Multispectral Optoacoustic Tomography (MSOT) Handheld Scanner in Patients With Crohn's Disease or Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn's Disease
Ulcerative Colitis
IBD
Keywords: Photoacoustics
Optoacoustics
Ultrasound
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: iThera Medical GmbH
First posted: 2015-12-04
Enrollment: 344
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Monocentric, prospective interventional study to assess the degree of disease activity with a multispectral optoacoustic tomography (MSOT) handheld scanner in patients with Crohn's disease or ulcerative colitis.

Detailed description: The proposed study is designed as a pilot study to evaluate the usefulness of MSOT for the evaluation of disease activity in IBD patients. As current methods for the evaluation of intestinal inflammation in IBD have relevant restrictions, new, non-invasive, quantitative, and accurate modalities are urgently needed. In comparison to other techniques, MSOT provides relevant advantages such as non-invasive imaging, high spatial resolution (this is of special importance for the evaluation of the intestine, which can be only a few millimeters thick), and highly sensitive detection of specific molecules such as total hemoglobin or oxy- /deoxygenated hemoglobin. These advantages suggest MSOT as an outstanding technique for evaluating disease activity in IBD.

The proposed study incorporates nearly no risk for participating patients and might provide relevant data for more a more in depth analysis of MSOT for IBD diagnosis.

Eligibility criteria: Inclusion Criteria:

* Histological verified Crohn's disease or ulcerative colitis
* Age \> 18 years

Exclusion Criteria:

* Age \< 18 years
* Mental retardation of the patient with restriction of general judgment and awareness

Primary outcomes:
measure: Correlation of MSOT-data with clinical activity scores of IBD
timeFrame: 12 month
measure: Correlation of MSOT-data with sonographic parameters
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Medical Department 1, University of Erlangen-Nürnberg
state: Bavaria
Study officials:
References:
citation: Knieling F, Neufert C, Hartmann A, Claussen J, Urich A, Egger C, Vetter M, Fischer S, Pfeifer L, Hagel A, Kielisch C, Gortz RS, Wildner D, Engel M, Rother J, Uter W, Siebler J, Atreya R, Rascher W, Strobel D, Neurath MF, Waldner MJ. Multispectral Optoacoustic Tomography for Assessment of Crohn's Disease Activity. N Engl J Med. 2017 Mar 30;376(13):1292-1294. doi: 10.1056/NEJMc1612455. No abstract available.
citation: Waldner MJ, Knieling F, Egger C, Morscher S, Claussen J, Vetter M, Kielisch C, Fischer S, Pfeifer L, Hagel A, Goertz RS, Wildner D, Atreya R, Strobel D, Neurath MF. Multispectral Optoacoustic Tomography in Crohn's Disease: Noninvasive Imaging of Disease Activity. Gastroenterology. 2016 Aug;151(2):238-40. doi: 10.1053/j.gastro.2016.05.047. Epub 2016 Jun 3. No abstract available.