Crohn DiseaseNCT06107179
Monitoring of Pediatric Inflammatory Bowel Diseases Using Multispectral Optoacoustic Tomography
An observational study of Crohn Disease and Ulcerative Colitis, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
In this clinical trial, the intestinal wall of pediatric patients with Crohns disease and Ulcerative Colitis will be assessed with multispectral optoacoustic tomography (MSOT) to characterize the optoacoustic signal of the intestinal wall and to monitor disease activity. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases
- What is being tested?
- Multispectral Optoacoustic Tomography
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 24 Jan 2024to 1 Feb 2026
- 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: IBD patients will be enrolled from the department of pediatric gastroenterology of the University hospital Erlangen, a primary care clinic
Who may be able to join
- Existing diagnosis of CD or UC, or suspected CD or UC at initial diagnosis.
- Age 2 - 18 years
- Written declaration of consent from parents / legal guardians
Who cannot join
- Pregnancy
- Nursing mothers
- Cardiopulmonary unstable patients*: Need for continuous cardiopulmonary monitoring
- Tattoo in the area of the examination field
- Subcutaneous fat > 3 cm
Trial locations and contacts
1 site in 1 country.
Ferdinand Knieling, MD contact
Germany1 site, 1 recruiting
- Recruiting
University Hospital Erlangen
Erlangen, Bavaria, 91054
Ferdinand Knieling, MD, +49 9131 85 33118, ferdinand.knieling@uk-erlangen.de
Adrian Regensburger, MD, +49 9131 85 33118, adrian.regensburger@uk-erlangen.de
About this study
Official title: Non-invasive Monitoring of Disease Activity in Pediatric Inflammatory Bowel Diseases Using Multispectral Optoacoustic Tomography
In this clinical trial, the intestinal wall of pediatric patients with Crohns disease and Ulcerative Colitis will be assessed with multispectral optoacoustic tomography (MSOT) to characterize the optoacoustic signal of the intestinal wall and to monitor disease activity.
The goal of this clinical trial is to compare the optoacoustic signal in the intestinal wall of children with inflammatory bowel diseases. The main questions it aims to answer are:
- How does the optoacoustic signal in children with inflammatory bowel diseases change over time?
- How does the optoacoustic signal in children with inflammatory bowel diseases change when they receive therapy? Participants will be examined with multispectral optoacoustic tomography.
Read the detailed description
In this study, the disease activity of children and adolescents with inflammatory bowel disease (IBD) will be assessed non-invasively by multispectral optoacoustic tomography (MSOT). IBDs play an important role in pediatric and adolescent medicine. The most common entities in the IBS group are Crohn's disease (CD) and ulcerative colitis (UC). Patients with CD develop chronic intermittent transmural inflammation of the gastrointestinal (GI) tract. Symptoms include diarrhea, hematochezia, abdominal pain, and malnutrition. Complications of the disease include fistula formation, perforations, and bleeding.The basis for many clinical decisions is the detection of disease activity.There are limitations to previous imaging methods for routine monitoring that are particularly relevant in pediatric and adolescent medicine.The use of contrast media, sedation, and invasive procedures are a burden for pediatric patients*.Multispectral optoacoustic tomography (MSOT) offers a radiation-free and noninvasive alternative for detecting disease activity. Quantitative assessment of hemoglobin signal in the bowel wall of patients with CD could previously be correlated with endoscopically detected disease activity. The aim of this study is to evaluate whether MSOT also allows monitoring of chronic inflammatory diseases in children. For this purpose, children in different stages of disease who regularly receive intravenous therapeutic administrations of biologics (e.g. infliximab) in our hospital will be examined. The investigators think that by means of MSOT different stages and courses of the diseases could be measured non-invasively and thus invasive measures in children could be reduced.
- Being tested
- Multispectral Optoacoustic Tomography
- Keywords
- MSOT, Optoacoustics, Photoacoustics
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multispectral Optoacoustic TomographyDiagnostic test
In MSOT, laser light is emitted into the target tissue via a handheld probe. Thermoelastic expansion of various molecules in the target area generates ultrasound waves that are detected by the transducer. The detected signals are reconstructed into images using algorithms. Spectral analysis of the optoacoustic signal at different wavelengths in the near-infrared range can detect individual chromophores, such as oxygenated and deoxygenated hemoglobin.
| Study group | Role | What they receive |
|---|---|---|
| Crohns Disease | Patients with Crohns Disease Receives: Diagnostic Test: Multispectral Optoacoustic Tomography | |
| Ulcerative Colitis | Patients with Ulcerative Colitis Receives: Diagnostic Test: Multispectral Optoacoustic Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
MSOT signal for hemoglobin in the intestinal wall of participants
Longitudinal analysis of MSOT signal for oxygenated and deoxygenated hemoglobin in the intestinal wall of children and adolescents with CD and UC.
Measured: 6 - 12 months
Secondary outcomes (12)
Quantitative comparison of the signal of oxygenated and deoxygenated hemoglobin measured by MSOT in inflamed and non-inflamed intestinal wall sections of children and adolescents with CD and UC.
Quantitative comparison of the signal of oxygenated and deoxygenated hemoglobin measured by MSOT in inflamed and non-inflamed intestinal wall sections of children and adolescents with CD and UC.
Measured: 6 - 12 months
Quantitative comparison of oxygenated and deoxygenated hemoglobin signal measured by MSOT in different intestinal wall sections of children and adolescents with CD and UC.
Quantitative comparison of oxygenated and deoxygenated hemoglobin signal measured by MSOT in different intestinal wall sections of children and adolescents with CD and UC.
Measured: 6 - 12 months
-Quantitative comparison of the quantitative fraction of fibrosis/collagen signal determined by MSOT in intestinal walls of children with IBD of different entities (CD and UC)
-Quantitative comparison of the quantitative fraction of fibrosis/collagen signal determined by MSOT in intestinal walls of children with IBD of different entities (CD and UC)
Measured: 6 - 12 months
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) derived by MSOT in arbitrary units (a.u.)
Measured: 6 - 12 months
Optoacoustic spectrum in a.u
Optoacoustic spectrum in the intestinal wall of children with different entities of IBD (CD vs. UC) derived by MSOT in arbitrary units (a.u.)
Measured: 6 - 12 months
Endoscopic extent of inflammation (if applicable)
Assessment of inflammation in endoscopies within different entities of IBD (CD vs. UC)
Measured: 6 - 12 months
Histological extent of inflammation and fibrosis (if applicable)
Assessment of inflammation and fibrosis in histological samples from biopsies within different entities of IBD (CD vs. UC)
Measured: 6 - 12 months
Clinical evaluation
Assessement of clinical disease status by PCDAI or PUCAI according to the CED within different entities of IBD (CD vs. UC)
Measured: 6 - 12 months
Ultrasound
Assessment of disease status by ultrasound within different entities of IBD (CD vs. UC)
Measured: 6 - 12 months
Laboratory parameters (blood - c-reactive protein (CrP)) (if applicable)
Assessment of disease status by laboratory parameters (CrP) within different entities of IBD (CD vs. UC)
Measured: 6 - 12 months
Laboratory parameters (stool - Calprotectin) (if applicable)
Assessment of disease status by laboratory parameters (Calprotectin) within different entities of IBD (CD vs. UC)
Measured: 6 - 12 months
MRI (if applicable)
Assessment of disease status by MRI within different entities of IBD (CD vs. UC)
Measured: 6 - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start24 Jan 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrian P Regensburger, Principal investigator, Childrens Hospital of the University hospital of Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107179
- Sponsor's protocol ID
- 23-278-Bm
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2023
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Monitoring of Disease Activity in Pediatric Inflammatory Bowel Diseases Using Multispectral Optoacoustic Tomography
- ClinicalTrials.gov ID
- NCT06107179
- Acronym / sponsor ID
- 23-278-Bm
- Keywords
- MSOT, Optoacoustics, Photoacoustics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this clinical trial, the intestinal wall of pediatric patients with Crohns disease and Ulcerative Colitis will be assessed with multispectral optoacoustic tomography (MSOT) to characterize the optoacoustic signal of the intestinal wall and to monitor disease activity.
The goal of this clinical trial is to compare the optoacoustic signal in the intestinal wall of children with inflammatory bowel diseases. The main questions it aims to answer are:
- How does the optoacoustic signal in children with inflammatory bowel diseases change over time?
- How does the optoacoustic signal in children with inflammatory bowel diseases change when they receive therapy? Participants will be examined with multispectral optoacoustic tomography.
Detailed description
In this study, the disease activity of children and adolescents with inflammatory bowel disease (IBD) will be assessed non-invasively by multispectral optoacoustic tomography (MSOT). IBDs play an important role in pediatric and adolescent medicine. The most common entities in the IBS group are Crohn's disease (CD) and ulcerative colitis (UC). Patients with CD develop chronic intermittent transmural inflammation of the gastrointestinal (GI) tract. Symptoms include diarrhea, hematochezia, abdominal pain, and malnutrition. Complications of the disease include fistula formation, perforations, and bleeding.The basis for many clinical decisions is the detection of disease activity.There are limitations to previous imaging methods for routine monitoring that are particularly relevant in pediatric and adolescent medicine.The use of contrast media, sedation, and invasive procedures are a burden for pediatric patients*.Multispectral optoacoustic tomography (MSOT) offers a radiation-free and noninvasive alternative for detecting disease activity. Quantitative assessment of hemoglobin signal in the bowel wall of patients with CD could previously be correlated with endoscopically detected disease activity. The aim of this study is to evaluate whether MSOT also allows monitoring of chronic inflammatory diseases in children. For this purpose, children in different stages of disease who regularly receive intravenous therapeutic administrations of biologics (e.g. infliximab) in our hospital will be examined. The investigators think that by means of MSOT different stages and courses of the diseases could be measured non-invasively and thus invasive measures in children could be reduced.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crohns Disease | – | Diagnostic Test: Multispectral Optoacoustic TomographyPatients with Crohns Disease |
| Ulcerative Colitis | – | Diagnostic Test: Multispectral Optoacoustic TomographyPatients with Ulcerative Colitis |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- IBD patients will be enrolled from the department of pediatric gastroenterology of the University hospital Erlangen, a primary care clinic
Key inclusion criteria (3 listed)
- Existing diagnosis of CD or UC, or suspected CD or UC at initial diagnosis.
- Age 2 - 18 years
- Written declaration of consent from parents / legal guardians
Key exclusion criteria (5 listed)
- Pregnancy
- Nursing mothers
- Cardiopulmonary unstable patients*: Need for continuous cardiopulmonary monitoring
- Tattoo in the area of the examination field
- Subcutaneous fat > 3 cm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multispectral Optoacoustic TomographyIn MSOT, laser light is emitted into the target tissue via a handheld probe. Thermoelastic expansion of various molecules in the target area generates ultrasound waves that are detected by the transducer. The detected signals are reconstructed into images using algorithms. Spectral analysis of the optoacoustic signal at different wavelengths in the near-infrared range can detect individual chromophores, such as oxygenated and deoxygenated hemoglobin. | Diagnostic test | Crohns Disease, Ulcerative Colitis |
Primary outcome
MSOT signal for hemoglobin in the intestinal wall of participants
Time frame: 6 - 12 months
Longitudinal analysis of MSOT signal for oxygenated and deoxygenated hemoglobin in the intestinal wall of children and adolescents with CD and UC.
12 secondary outcomes
Quantitative comparison of the signal of oxygenated and deoxygenated hemoglobin measured by MSOT in inflamed and non-inflamed intestinal wall sections of children and adolescents with CD and UC.
Time frame: 6 - 12 months
Quantitative comparison of oxygenated and deoxygenated hemoglobin signal measured by MSOT in different intestinal wall sections of children and adolescents with CD and UC.
Time frame: 6 - 12 months
-Quantitative comparison of the quantitative fraction of fibrosis/collagen signal determined by MSOT in intestinal walls of children with IBD of different entities (CD and UC)
Time frame: 6 - 12 months
Quantitative amount of single wavelength signal in a.u.
Time frame: 6 - 12 months
Optoacoustic spectrum in a.u
Time frame: 6 - 12 months
Endoscopic extent of inflammation (if applicable)
Time frame: 6 - 12 months
Histological extent of inflammation and fibrosis (if applicable)
Time frame: 6 - 12 months
Clinical evaluation
Time frame: 6 - 12 months
Ultrasound
Time frame: 6 - 12 months
Laboratory parameters (blood - c-reactive protein (CrP)) (if applicable)
Time frame: 6 - 12 months
Laboratory parameters (stool - Calprotectin) (if applicable)
Time frame: 6 - 12 months
MRI (if applicable)
Time frame: 6 - 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ferdinand Knieling, MD contact
Adrian P Regensburger principal investigator
Childrens Hospital of the University hospital of Erlangen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adrian P Regensburger, MD (+49 91318541151, adrian.regensburger@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MSOT signal for hemoglobin in the intestinal wall of participants (time frame: 6 - 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2024.