NCT04650867

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

March 22, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
Last Updated

April 18, 2023

Status Verified

February 1, 2021

Enrollment Period

1.7 years

First QC Date

November 17, 2020

Last Update Submit

April 12, 2023

Conditions

Crohn's DiseaseUlcerative ColitisIBD

Keywords

MSOTCrohn's DiseaseCrohn DiseaseCDUlcerative ColitisUCchronic inflammatory bowel diseaseIBD

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Quantitative amount of fibrosis/collagen signal in a.u.

    Single time point (1 day)

  • Quantitative amount of single wavelength signal in a.u.

    Single time point (1 day)

  • Optoacoustic spectrum in a.u.

    Single time point (1 day)

  • Endoscopic extent of inflammation

    Single time point (1 day), +/- 7 days from MSOT Imaging

  • Histological extent of inflammation and fibrosis

    Single time point (1 day), +/- 7 days from MSOT Imaging

  • +5 more secondary outcomes

Study Arms (3)

Patients with Crohn's disease

Patients diagnosed or with suspected Crohn's disease.

Device: Multispectral Optoacoustic Tomography (MSOT)

Patients with Ulcerative colitis

Patients diagnosed or with suspected Ulcerative colitis

Device: Multispectral Optoacoustic Tomography (MSOT)

Patients with unclassified inflammatory bowel disease (U-IBD)

Patients diagnosed or with suspected unclassified inflammatory bowel disease (U-IBD)

Device: Multispectral Optoacoustic Tomography (MSOT)

Interventions

Multispectral Optoacoustic Tomography (MSOT)DEVICE

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

Patients with Crohn's diseasePatients with Ulcerative colitisPatients with unclassified inflammatory bowel disease (U-IBD)

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients from the Department of Pediatric and Adolescent Medicine, University Hospital Erlangen

You may qualify if:

  • CD patients
  • Diagnosis CD or suspected CD at initial diagnosis
  • Indication for endoscopy and sampling (biopsy)
  • UC patients
  • Diagnosis UC or suspected UC at initial diagnosis
  • Indication for endoscopy and sampling (biopsy)
  • U-IBD patients
  • Diagnosis U-IBD or suspected IBD at initial diagnosis
  • Indication for endoscopy and sampling (biopsy)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Erlangen

Erlangen, Bavaria, 91054, Germany

Location

Related Publications (10)

  • 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.

    PMID: 20564651BACKGROUND

  • 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.

    PMID: 26414706BACKGROUND

  • 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.

    PMID: 19944797BACKGROUND

  • 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.

    PMID: 26284542BACKGROUND

  • 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.

    PMID: 24909831BACKGROUND

  • 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.

    PMID: 22773060BACKGROUND

  • 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.

    PMID: 25474283BACKGROUND

  • 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.

    PMID: 21866493BACKGROUND

  • 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.

    PMID: 28355498BACKGROUND

  • 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.

    PMID: 27269244BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Routine biopsies

MeSH Terms

Conditions

Crohn DiseaseColitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • Ferdinand Knieling, MD

    Department of Pediatric- and Adolescent Medicine, FAU Erlangen-Nürneberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2020

First Posted

December 3, 2020

Study Start

March 22, 2021

Primary Completion

December 20, 2022

Study Completion

December 20, 2022

Last Updated

April 18, 2023

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)