Multiparametric Ultrasound Study in Diagnosing GvHD

NCT05790135 | Suspended

• 1 other identifier: 4926
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The study evaluate the role of the use of bed-side multiparametric ultrasound study in the diagnosis of gastrointestinal acute graft-versus host disease (aGvHD) in patients underwent allogenic stem cell transplantation

Conditions

Intestinal GVHD

Keywords

SCT; GvHD; gastrointestinal; CEUS; SWE

Outcome Measures

Primary Outcomes (2)

• Sensitivity of bed-side multiparametric ultrasound study in gut-GvHD diagnosis will be measured and reported

  Primary endpoint of the study is to evaluate the sensitivity of bed-side multiparametric ultrasound study in the diagnosis of gastrointestinal aGvHD in patients underwent to allogenic transplant

  Onset of gastrointestinal symptoms within 100 days from transplant

• Specificity of bed-side multiparametric ultrasound study in gut-GvHD diagnosis will be measured and reported

  Primary endpoint of the study is to evaluate the specificity of bed-side multiparametric ultrasound study in the diagnosis of gastrointestinal aGvHD in patients underwent to allogenic transplant

  Onset of gastrointestinal symptoms within 100 days from transplant

Study Arms (1)

Multiparametric ultrasound evaluation

EXPERIMENTAL

Multiparametric ultrasound evaluation will be applied to all patients who will develop diarrhea above 500 ml per day.

Device: shear wave elastography

Interventions

shear wave elastography DEVICE

Shear wave elastography and CEUS will be used to evaluate the reliability in diagnosing graft versus host disease of the gut after hematopoietic stem cell transplantation

Also known as: contrast enhanced ultrasould (CEUS)

Multiparametric ultrasound evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli

Rome, RM, 00168, Italy

Location

Study Officials

• Elisabetta Metafuni, MD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 30, 2023
• Study Start: October 14, 2022
• Primary Completion: August 12, 2025
• Study Completion: December 31, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)