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Crohn's DiseasePED_MSOT_IBDNCT04650867

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

An observational study of Crohn's Disease and Ulcerative Colitis, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 2 to 18 years
Conditions the study is for
Crohn's Disease, Ulcerative Colitis, IBD
What is being tested?
Multispectral Optoacoustic Tomography (MSOT)
Type of treatment
Medical device
How many people
23 participants
Where
1 siteGermany
Study dates
22 Mar 2021to 20 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Who may be able to join

  • 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)
Show all 9Show fewer
  • U-IBD patients
  • Diagnosis U-IBD or suspected IBD at initial diagnosis
  • Indication for endoscopy and sampling (biopsy)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital Erlangen

    Erlangen, Bavaria, 91054

Other trials in Germany

About this study

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

Read the 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.

Being tested
Multispectral Optoacoustic Tomography (MSOT)
Keywords
MSOT, Crohn's Disease, Crohn Disease, CD, Ulcerative Colitis, UC, chronic inflammatory bowel disease, IBD
Medical subject headings
Crohn Disease, Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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).

Study groups in NCT04650867
Study groupRoleWhat they receive
Patients with Crohn's diseasePatients diagnosed or with suspected Crohn's disease.
Receives: Device: Multispectral Optoacoustic Tomography (MSOT)
Patients with Ulcerative colitisPatients diagnosed or with suspected Ulcerative colitis
Receives: Device: Multispectral Optoacoustic Tomography (MSOT)
Patients with unclassified inflammatory bowel disease (U-IBD)Patients diagnosed or with suspected unclassified inflammatory bowel disease (U-IBD)
Receives: Device: Multispectral Optoacoustic Tomography (MSOT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.)

    Measured: Single time point (1 day)

Secondary outcomes (10)

  1. 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.)

    Measured: Single time point (1 day)

  2. 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.)

    Measured: Single time point (1 day)

  3. 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.)

    Measured: Single time point (1 day)

  4. Endoscopic extent of inflammation

    Assessment of inflammation in endoscopies within different entities of IBD (CD vs. UC vs. U-IBD)

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

  5. 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)

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

  6. 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)

    Measured: Single time point (1 day)

  7. Ultrasound

    Assessment of disease status by ultrasound within different entities of IBD (CD vs. UC vs. U-IBD)

    Measured: Single time point (1 day), +/- 1 day from MSOT Imaging

  8. 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)

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

  9. Laboratory parameters (stool - Calprotectin)

    Assessment of disease status by laboratory parameters (Calprotectin) within different entities of IBD (CD vs. UC vs. U-IBD)

    Measured: Single time point (1 day), +/- 14 day from MSOT Imaging

  10. MRI

    Assessment of disease status by MRI (if applicable) within different entities of IBD (CD vs. UC vs. U-IBD)

    Measured: Single time point (1 day), +/- 14 day from MSOT Imaging

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2020
  2. Study start22 Mar 2021
  3. Primary completion20 Dec 2022
  4. Study completion20 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04650867
Sponsor's protocol ID
351_20B
Acronym
PED_MSOT_IBD
Status last verified
Feb 2021
First submitted
17 Nov 2020
Last updated
18 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20564651

  • 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.

    PubMed 26414706

  • 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.

    PubMed 19944797

  • 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.

    PubMed 26284542

  • 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.

    PubMed 24909831

  • 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.

    PubMed 22773060

  • 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.

    PubMed 25474283

  • 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.

    PubMed 21866493

  • 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.

    PubMed 28355498

  • 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.

    PubMed 27269244

Questions about this trial

What is this clinical trial studying?

An observational study of Crohn's Disease and Ulcerative Colitis, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quantitative amount of oxygenated/deoxygenated hemoglobin in a.u. (time frame: Single time point (1 day)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04650867, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.

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