Multispectral Optoacoustic Tomography (MSOT) for the Evaluation of Disease Activity in Inflammatory Bowel Diseases (IBD)

Ulcerative Colitis Clinical Trial

— MSOT_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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02622139
• Other study ID #: 252_15B
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: December 2019

Study information

• Verified date: December 2019
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 344
• Est. completion date: December 2019
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• IBD
• Ulcer
• Ulcerative Colitis

Intervention

Device:
• Multispectral Optoacoustic Tomography (MSOT)
MSOT for the evaluation of disease activity in IBD patients

Locations

Country	Name	City	State
Germany	Medical Department 1, University of Erlangen-Nürnberg	Erlangen	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	iThera Medical GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Knieling F, Neufert C, Hartmann A, Claussen J, Urich A, Egger C, Vetter M, Fischer S, Pfeifer L, Hagel A, Kielisch C, Görtz RS, Wildner D, Engel M, Röther J, Uter W, Siebler J, Atreya R, Rascher W, Strobel D, Neurath MF, Waldner MJ. Multispectral Optoacou — View 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 A — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of MSOT-data with clinical activity scores of IBD		12 month
Primary	Correlation of MSOT-data with sonographic parameters		12 month