← Back to Search

Diagnostic Test

Ultrasound Elastography for Sinusoidal Obstruction Syndrome

Phase 4

Waitlist Available

Led By Shewin Chan, MD, PhD

Research Sponsored by Children's Mercy Hospital Kansas City

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 100 days post transplant

Awards & highlights

Study Summary

This trial is testing whether a diagnostic tool, called SWE, can help earlier identify patients with a condition called SOS who would benefit from treatment with defibrotide. The investigators have completed a preliminary study that showed SWE may be able to diagnose SOS nine days earlier than current clinical criteria. This new study will enroll 80 additional patients to help optimize the timing of SWE testing and compare it against newly published clinical criteria.

Who is the study for?

This trial is for children and adults, aged 1 month to 21 years, who are undergoing myeloablative stem cell transplants. It's not suitable for those with conditions that may interfere with the study or if ultrasound imaging isn't possible due to patient cooperation issues.Check my eligibility

What is being tested?

The trial is testing whether Ultrasound Shear Wave Elastography (US SWE) can detect Sinusoidal Obstruction Syndrome (SOS) earlier than current methods in patients after bone marrow transplants. The goal is to validate US SWE as an early diagnostic tool.See study design

What are the potential side effects?

Ultrasound Shear Wave Elastography (US SWE), used in this study, has no known side effects and is considered a safe procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 100 days post transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~100 days post transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 100 days post transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

SWE Accuracy for Diagnosing SOS

Secondary outcome measures

Evaluate SWE Accuracy for Severity Grading

Trial Design

1Treatment groups

Experimental Treatment

Group I: All Patients EnrolledExperimental Treatment1 Intervention

All patients will undergo limited abdominal US with Doppler and SWE once a week upon admission for conditioning until the patient day +30 BMT or discharge, whichever comes first. Additional ultrasounds will also be performed if SOS is suspected.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ultrasound Examination

2017

Completed Phase 4

~410

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Children's Mercy Hospital Kansas CityLead Sponsor

248 Previous Clinical Trials

935,938 Total Patients Enrolled

Shewin Chan, MD, PhDPrincipal InvestigatorChildren's Mercy Hospital Kansas City

Media Library

Ultrasound Examination (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT03858530 — Phase 4

Sinusoidal Obstruction Syndrome Research Study Groups: All Patients Enrolled

Sinusoidal Obstruction Syndrome Clinical Trial 2023: Ultrasound Examination Highlights & Side Effects. Trial Name: NCT03858530 — Phase 4

Ultrasound Examination (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03858530 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being recruited for this research?

"Clinicaltrials.gov reports that, while this trial was initially listed on May 1st 2018 and most recently modified in June 3rd 2022, there is no current recruitment of participants. However, 1417 other clinical trials are actively searching for patients at the present moment."

Answered by AI