Using ultrasound to diagnose intestinal graft-versus-host disease
Evaluation of the Role of Multiparametric Ultrasound Study in Discriminating Among Intestinal Complications After Hematopoietic Stem Cell Transplantation. A Pilot Study.
NA · Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT05790135
This study is testing if a special ultrasound can help doctors diagnose intestinal graft-versus-host disease in patients who have had a stem cell transplant and are experiencing severe diarrhea.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other) |
| Locations | 1 site (Rome, RM) |
| Trial ID | NCT05790135 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of bedside multiparametric ultrasound, specifically shear wave elastography (SWE), in diagnosing gastrointestinal acute graft-versus-host disease (aGvHD) in patients who have undergone allogenic stem cell transplantation. Patients experiencing significant diarrhea within 100 days post-transplant will be monitored using ultrasound to assess intestinal changes and determine the presence of aGvHD. The study aims to provide a non-invasive diagnostic tool that could enhance the understanding of intestinal involvement in aGvHD. Stool cultures and colonoscopy will also be utilized for comprehensive assessment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone their first allogenic stem cell transplant and developed diarrhea suggestive of aGvHD within the specified timeframe.
Not a fit: Patients who have had previous allogenic stem cell transplants or those with severe cardiomyopathy or respiratory issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and more accurate diagnosis of intestinal aGvHD, improving patient management and outcomes.
How similar studies have performed: While there is limited data on the use of SWE specifically for aGvHD, similar ultrasound techniques have shown promise in assessing gastrointestinal conditions in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years; * Submitted to first allogeneic stem cell transplant during the 12 months period of enrollment of the study; * Diarrhea onset between day 0 and day +100 from transplant; * Signed informed consent. Exclusion Criteria: * Previous allogeneic stem cell transplantation; * Patients refusing to sign informed consent for the study; * Patients affected by severe cardiomyopathy and respiratory distress/insufficiency; * Patients unable to fully understand and accept study protocol for various problems
Where this trial is running
Rome, RM
- Fondazione Policlinico Universitario Agostino Gemelli — Rome, RM, Italy (RECRUITING)
Study contacts
- Principal investigator: Elisabetta Metafuni, MD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Elisabetta Metafuni, MD
- Email: elisabetta.metafuni@policlinicogemelli.it
- Phone: +39 3204475207
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: Intestinal GVHD, SCT, GvHD, gastrointestinal, CEUS, SWE