Monitoring pediatric inflammatory bowel diseases with advanced imaging technology
Non-invasive Monitoring of Disease Activity in Pediatric Inflammatory Bowel Diseases Using Multispectral Optoacoustic Tomography
This study is testing a new imaging technology to see if it can help doctors better monitor and understand how Crohn's disease and ulcerative colitis affect children without using invasive methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Sponsor | University of Erlangen-Nürnberg Medical School Academic / other |
| Drugs / interventions | infliximab, radiation |
| Locations | 1 site (Erlangen, Bavaria) |
| Trial ID | NCT06107179 on ClinicalTrials.gov |
What this trial studies
This clinical trial utilizes multispectral optoacoustic tomography (MSOT) to non-invasively assess the intestinal wall of pediatric patients diagnosed with Crohn's disease and ulcerative colitis. The study aims to characterize the optoacoustic signals associated with disease activity and monitor changes over time and in response to therapy. By comparing these signals, researchers hope to improve the understanding of disease progression and treatment efficacy in children with inflammatory bowel diseases. This approach seeks to overcome the limitations of traditional imaging methods that can be invasive and burdensome for young patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children and adolescents aged 2 to 18 years with a diagnosis or suspicion of Crohn's disease or ulcerative colitis.
Not a fit: Patients who are pregnant, nursing, or have significant cardiopulmonary instability may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective way to monitor disease activity in children with inflammatory bowel diseases.
How similar studies have performed: While the use of multispectral optoacoustic tomography is a novel approach, previous studies have shown promise in correlating optoacoustic signals with disease activity in similar contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Pregnancy * Nursing mothers * Cardiopulmonary unstable patients\*: Need for continuous cardiopulmonary monitoring * Tattoo in the area of the examination field * Subcutaneous fat \> 3 cm
Where this trial is running
Erlangen, Bavaria
- University Hospital Erlangen — Erlangen, Bavaria, Germany (Recruiting)
Study contacts
- Principal investigator: Adrian P Regensburger — Childrens Hospital of the University hospital of Erlangen
- Study coordinator: Adrian P Regensburger, MD
- Email: adrian.regensburger@uk-erlangen.de
- Phone: +49 91318541151
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.