Non Invasive Characterization of Pediatric Inflammatory Bowel Diseases Using Multispectral Optoacoustic Tomography

Ulcerative Colitis Clinical Trial

— PED_MSOT_IBD  

Official title:

Non Invasive Characterization of Pediatric Inflammatory Bowel Diseases Using Multispectral Optoacoustic Tomography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04650867
• Other study ID #: 351_20B
• Status: Completed
• Start date: March 22, 2021
• Est. completion date: December 20, 2022

Study information

• Verified date: February 2021
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• IBD
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

Device:
• Multispectral Optoacoustic Tomography (MSOT)
Non-invasive transcutaneous MSOT imaging of the bowel wall (terminal ileum, ascending caecum/colon, transverse colon, descending colon, and sigmoid colon).

Locations

Country	Name	City	State
Germany	University Hospital Erlangen	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

References & Publications (10)

Assa A, Avni I, Ben-Bassat O, Niv Y, Shamir R. Practice Variations in the Management of Inflammatory Bowel Disease Between Pediatric and Adult Gastroenterologists. J Pediatr Gastroenterol Nutr. 2016 Mar;62(3):372-7. doi: 10.1097/MPG.0000000000000943. — View Citation

Benchimol EI, Fortinsky KJ, Gozdyra P, Van den Heuvel M, Van Limbergen J, Griffiths AM. Epidemiology of pediatric inflammatory bowel disease: a systematic review of international trends. Inflamm Bowel Dis. 2011 Jan;17(1):423-39. doi: 10.1002/ibd.21349. — View Citation

Dignass A, Preiss JC, Aust DE, Autschbach F, Ballauff A, Barretton G, Bokemeyer B, Fichtner-Feigl S, Hagel S, Herrlinger KR, Jantschek G, Kroesen A, Kruis W, Kucharzik T, Langhorst J, Reinshagen M, Rogler G, Schleiermacher D, Schmidt C, Schreiber S, Schulze H, Stange E, Zeitz M, Hoffmann JC, Stallmach A. [Updated German guideline on diagnosis and treatment of ulcerative colitis, 2011]. Z Gastroenterol. 2011 Sep;49(9):1276-341. doi: 10.1055/s-0031-1281666. Epub 2011 Aug 24. No abstract available. German. — View 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. — View Citation

Preiss JC, Bokemeyer B, Buhr HJ, Dignass A, Hauser W, Hartmann F, Herrlinger KR, Kaltz B, Kienle P, Kruis W, Kucharzik T, Langhorst J, Schreiber S, Siegmund B, Stallmach A, Stange EF, Stein J, Hoffmann JC; German Society of Gastroenterology. [Updated German clinical practice guideline on "Diagnosis and treatment of Crohn's disease" 2014]. Z Gastroenterol. 2014 Dec;52(12):1431-84. doi: 10.1055/s-0034-1385199. Epub 2014 Dec 4. No abstract available. German. — View Citation

Rosen MJ, Dhawan A, Saeed SA. Inflammatory Bowel Disease in Children and Adolescents. JAMA Pediatr. 2015 Nov;169(11):1053-60. doi: 10.1001/jamapediatrics.2015.1982. — View Citation

Ruemmele FM, Veres G, Kolho KL, Griffiths A, Levine A, Escher JC, Amil Dias J, Barabino A, Braegger CP, Bronsky J, Buderus S, Martin-de-Carpi J, De Ridder L, Fagerberg UL, Hugot JP, Kierkus J, Kolacek S, Koletzko S, Lionetti P, Miele E, Navas Lopez VM, Paerregaard A, Russell RK, Serban DE, Shaoul R, Van Rheenen P, Veereman G, Weiss B, Wilson D, Dignass A, Eliakim A, Winter H, Turner D; European Crohn's and Colitis Organisation; European Society of Pediatric Gastroenterology, Hepatology and Nutrition. Consensus guidelines of ECCO/ESPGHAN on the medical management of pediatric Crohn's disease. J Crohns Colitis. 2014 Oct;8(10):1179-207. doi: 10.1016/j.crohns.2014.04.005. Epub 2014 Jun 6. — View Citation

Sauer CG, Kugathasan S. Pediatric inflammatory bowel disease: highlighting pediatric differences in IBD. Med Clin North Am. 2010 Jan;94(1):35-52. doi: 10.1016/j.mcna.2009.10.002. — View Citation

Turner D, Levine A, Escher JC, Griffiths AM, Russell RK, Dignass A, Dias JA, Bronsky J, Braegger CP, Cucchiara S, de Ridder L, Fagerberg UL, Hussey S, Hugot JP, Kolacek S, Kolho KL, Lionetti P, Paerregaard A, Potapov A, Rintala R, Serban DE, Staiano A, Sweeny B, Veerman G, Veres G, Wilson DC, Ruemmele FM; European Crohn's and Colitis Organization; European Society for Paediatric Gastroenterology, Hepatology, and Nutrition. Management of pediatric ulcerative colitis: joint ECCO and ESPGHAN evidence-based consensus guidelines. J Pediatr Gastroenterol Nutr. 2012 Sep;55(3):340-61. doi: 10.1097/MPG.0b013e3182662233. — 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 Activity. Gastroenterology. 2016 Aug;151(2):238-40. doi: 10.1053/j.gastro.2016.05.047. Epub 2016 Jun 3. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative amount of oxygenated/deoxygenated hemoglobin in a.u.	Oxygenated/deoxygenated hemoglobin signals in the intestinal/bowel wall of children with different entities of IBD (CD vs. UC vs. U-IBD) derived by MSOT in arbitrary units (a.u.)	Single time point (1 day)
Secondary	Quantitative amount of fibrosis/collagen signal in a.u.	fibrosis/collagen signals in the intestinal wall of children with different entities of IBD (CD vs. UC vs. U-IBD) derived by MSOT in arbitrary units (a.u.)	Single time point (1 day)
Secondary	Quantitative amount of single wavelength signal in a.u.	single wavelength signals in the intestinal wall of children with different entities of IBD (CD vs. UC vs. U-IBD) derived by MSOT in arbitrary units (a.u.)	Single time point (1 day)
Secondary	Optoacoustic spectrum in a.u.	Optoacoustic spectrum in the intestinal wall of children with different entities of IBD (CD vs. UC vs. U-IBD) derived by MSOT in arbitrary units (a.u.)	Single time point (1 day)
Secondary	Endoscopic extent of inflammation	Assessment of inflammation in endoscopies within different entities of IBD (CD vs. UC vs. U-IBD)	Single time point (1 day), +/- 7 days from MSOT Imaging
Secondary	Histological extent of inflammation and fibrosis	Assessment of inflammation and fibrosis in histological samples from biopsies within different entities of IBD (CD vs. UC vs. U-IBD)	Single time point (1 day), +/- 7 days from MSOT Imaging
Secondary	Clinical evaluation	Assessement of clinical disease status by PCDAI or PUCAI according to the CED within different entities of IBD (CD vs. UC vs. U-IBD)	Single time point (1 day)
Secondary	Ultrasound	Assessment of disease status by ultrasound within different entities of IBD (CD vs. UC vs. U-IBD)	Single time point (1 day), +/- 1 day from MSOT Imaging
Secondary	Laboratory parameters (blood - c-reaktive protein (CrP))	Assessment of disease status by laboratory parameters (CrP) within different entities of IBD (CD vs. UC vs. U-IBD)	Single time point (1 day), +/- 7 day from MSOT Imaging
Secondary	Laboratory parameters (stool - Calprotectin)	Assessment of disease status by laboratory parameters (Calprotectin) within different entities of IBD (CD vs. UC vs. U-IBD)	Single time point (1 day), +/- 14 day from MSOT Imaging
Secondary	MRI	Assessment of disease status by MRI (if applicable) within different entities of IBD (CD vs. UC vs. U-IBD)	Single time point (1 day), +/- 14 day from MSOT Imaging