Using ultrasound to monitor treatment in inflammatory bowel diseases
Prospective Study to Evaluate the Role of Contrast-enhanced Ultrasound (CEUS) and Elastography in Predicting Clinical and Endoscopic Remission (Deep Remission) in Inflammatory Bowel Disease
NA · Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT05987501
This study tests whether using special ultrasound techniques can help doctors see if treatment is working for people with inflammatory bowel diseases after a year.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other) |
| Locations | 1 site (Roma) |
| Trial ID | NCT05987501 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of dynamic contrast-enhanced ultrasound (D-CEUS) and shear wave elastography (SWE) in predicting deep remission in patients with inflammatory bowel diseases (IBD) after 12 months of treatment. The research focuses on the non-invasive and cost-effective nature of intestinal ultrasound, aiming to improve treatment monitoring and outcomes. By assessing various parameters, including bowel microvascularization and tissue stiffness, the study seeks to establish a correlation between ultrasound findings and clinical, endoscopic, and inflammatory indices.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Crohn's disease or Ulcerative Colitis who are starting biologic treatment.
Not a fit: Patients who may not benefit include those with undetermined colitis, obesity preventing visualization, or those with contraindications to ultrasound contrast agents.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of inflammatory bowel diseases, enhancing patient outcomes.
How similar studies have performed: Other studies have shown promise in using ultrasound for monitoring IBD, but the specific combination of D-CEUS and SWE in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * written informed consent * diagnosis of Crohn's disease or Ulcerative Colitis * indication to start biologic treatment according to international guidelines * affected intestinal segment detectable in B-mode ultrasound Exclusion Criteria: * induction of biologic therapy in prophylaxis after surgery in Crohn's disease * lack of visualization of affected intestinal tract (eg. obesity) * diagnosis of undetermined colitis * hearth failure * known allergy to ultrasound contrast agents * pregnancy * lactation
Where this trial is running
Roma
- Fondazione Policlinico Gemelli IRCCS — Roma, Italy (RECRUITING)
Study contacts
- Study coordinator: Maria Assunta Zocco
- Email: mariaassunta.zocco@policlinicogemelli.it
- Phone: 00393470597805
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.
Conditions: Inflammatory Bowel Diseases