Using intestinal ultrasound to predict vedolizumab response and transmural healing in early Crohn's disease
Value of Intestinal Ultrasound in Predicting Vedolizumab Response and Assessing Transmural Healing in Early Crohn's Disease: A Multicenter, Prospective Study
This project will test if intestinal ultrasound can predict how well vedolizumab works and show transmural healing in adults with early Crohn's disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The Third Xiangya Hospital of Central South University Academic / other |
| Drugs / interventions | Vedolizumab, upadacitinib |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT07093294 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, prospective observational study enrolling adults with early Crohn's disease who are biologic- and advanced-therapy–naïve. Participants will receive baseline endoscopy and intestinal ultrasound (IUS) and begin vedolizumab within one month of those assessments, with follow-up imaging and clinical monitoring to track response and healing. The study will correlate baseline and longitudinal IUS findings with clinical outcomes and mucosal/transmural healing. Results aim to identify ultrasound features that predict which patients benefit most from vedolizumab.
Who should consider this trial
Good fit: Adults aged 18–80 with early Crohn's disease (disease duration ≤18 months), biologic- and advanced-therapy–naïve, without fistulas, strictures, or prior intestinal surgery, and who are planned to start vedolizumab are ideal candidates.
Not a fit: Patients with long-standing or complicated Crohn's disease (stricturing or penetrating complications), prior biologic exposure or intestinal surgery, or contraindications to vedolizumab or contrast agents are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could let doctors use a noninvasive ultrasound to predict and monitor vedolizumab response, helping personalize treatment and avoid ineffective therapy.
How similar studies have performed: Vedolizumab has demonstrated clinical remission and mucosal healing in GEMINI and VERSIFY, but using intestinal ultrasound specifically to predict response and transmural healing is relatively novel with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years and ≤ 80 years; * Early CD patients (disease duration ≤18 months, biologic-naïve and treatment-naïve for advanced therapies, without complications such as fistulas or strictures) * Vedolizumab therapy is proposed to be applied within 1 month after baseline endoscopy and intestinal ultrasound,; * No history of intestinal surgery; * Clearly understand, voluntarily participate in the study, and sign an informed consent form. Exclusion Criteria: * Contraindications to vedolizumab: allergy, active tuberculosis or other active infections, moderate-to-severe heart failure (NYHA grade III/ IV), demyelinating lesions of the nervous system, live vaccination within the last 3 months, pregnancy and lactation; * Patients with a history of extensive colectomy or recent proposed colectomy, history of colonic mucosal dysplasia; * Hypersensitivity to the components of SonoVue contrast media.
Where this trial is running
Changsha, Hunan
- The Third Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Tian Li
- Email: f3tianli@outlook.com
- Phone: 0731-13574843423
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.