Clinical trial NCT04650867: Non Invasive Characterization of Pediatric Inflammatory Bowel Diseases Using Multispectral Optoacoustic Tomography
Official title: Non Invasive Characterization of Pediatric Inflammatory Bowel Diseases Using Multispectral Optoacoustic Tomography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Ulcerative Colitis
IBD
Keywords: MSOT
Crohn's Disease
Crohn Disease
CD
Ulcerative Colitis
UC
chronic inflammatory bowel disease
IBD
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 23
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the Department of Pediatric and Adolescent Medicine, University Hospital Erlangen

Brief summary: Monocentric, prospective observational study to assess bowel inflammation in children with chronic inflammatory bowel disease (IBD) using multispectral optoacoustic tomography (MSOT).

Detailed description: Inflammatory bowel diseases (IBD) play a major role in child and adolescent medicine. 25 % of patients with IBD are younger than 18 years of age at diagnosis and 25 % of those are even younger than 10 years of age at disease onset. The incidence of IBD in children and adolescents is 5-11/100 000 in Germany. IBD comprises mainly two entities, namely Crohn's disease (CD) and ulcerative colitis (UC). Patients with CD develop chronic and intermittent transmural inflammation of the gastrointestinal tract, which manifests with symptoms like diarrhea, hematochezia, abdominal pain, fatigue and malnutrition. This often results in weight loss and an increased risk of numerous complications such as the development of fistulas, perforations and intestinal strictures. In addition, growth disturbances and delayed onset of puberty are more frequent. Overall, the course of the disease can only be compared between children and adults to a very limited extent, as the disease often progresses more rapidly and severely in children. Accordingly, the procedure and recommendations for children with CD differ from those of adults. In addition to clinical scores, laboratory chemical parameters (blood count, CrP, calprotectin) and imaging diagnostics (endoscopy, ultrasound, MRT) are available to assess disease activity. However, the latter are only of limited use for routine monitoring due to their invasiveness, the need for sedation and the use of contrast agents. Multispectral Optoacoustic Tomograph (MSOT) on the other hand allows, comparable to sonography, a non-invasive, quantitative imaging of the composition of target tissues in children without sedation. Previous studies have shown that the quantitative determination of hemoglobin provides information on blood flow and inflammatory activity in the bowel of adult patients with Crohn's disease. In this pilot study, the intestinal wall of children will be characterized by MSOT to differentiate between CD, UC, and unclassified inflammatory bowel disease (U-IBD) and to quantify changes and correlate them with routine parameters. This could lead to a new possibility of non-invasive evaluation of disease forms and activity comparable to previous findings in adult patients with CD.

Eligibility criteria: Inclusion Criteria:

1. CD patients

   * Diagnosis CD or suspected CD at initial diagnosis
   * Indication for endoscopy and sampling (biopsy)
2. UC patients

   * Diagnosis UC or suspected UC at initial diagnosis
   * Indication for endoscopy and sampling (biopsy)
3. U-IBD patients

   * Diagnosis U-IBD or suspected IBD at initial diagnosis
   * Indication for endoscopy and sampling (biopsy)

Exclusion Criteria:

* Pregnancy
* Nursing mothers
* Unstable patients: Need for continuous cardiopulmonary monitoring (ECG and pulse oximetry)
* Tattoo in the field of investigation
* Subcutaneous fat tissue over 3 cm
* Lack of written consent

Primary outcomes:
measure: Quantitative amount of oxygenated/deoxygenated hemoglobin in a.u.
timeFrame: Single time point (1 day)
Secondary outcomes:
measure: Quantitative amount of fibrosis/collagen signal in a.u.
timeFrame: Single time point (1 day)
measure: Quantitative amount of single wavelength signal in a.u.
timeFrame: Single time point (1 day)
measure: Optoacoustic spectrum in a.u.
timeFrame: Single time point (1 day)
measure: Endoscopic extent of inflammation
timeFrame: Single time point (1 day), +/- 7 days from MSOT Imaging
measure: Histological extent of inflammation and fibrosis
timeFrame: Single time point (1 day), +/- 7 days from MSOT Imaging
measure: Clinical evaluation
timeFrame: Single time point (1 day)
measure: Ultrasound
timeFrame: Single time point (1 day), +/- 1 day from MSOT Imaging
measure: Laboratory parameters (blood - c-reaktive protein (CrP))
timeFrame: Single time point (1 day), +/- 7 day from MSOT Imaging
measure: Laboratory parameters (stool - Calprotectin)
timeFrame: Single time point (1 day), +/- 14 day from MSOT Imaging
measure: MRI
timeFrame: Single time point (1 day), +/- 14 day from MSOT Imaging
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Hospital Erlangen
state: Bavaria
Study officials:
affiliation: Department of Pediatric- and Adolescent Medicine, FAU Erlangen-Nürneberg
name: Ferdinand Knieling, MD
role: PRINCIPAL_INVESTIGATOR
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