Ultrasound Elastography for Sinusoidal Obstruction Syndrome

N/A

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 study period

Awards & highlights

No Placebo-Only Group

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.

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.

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 ~ daily through study completion assessed for up to 100 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~daily through study completion assessed for up to 100 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and daily through study completion assessed for up to 100 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Days Between SWE Exams for VOD/SOS

Secondary study objectives

CEUS Variables Versus Grayscale and Doppler Variables

Determine if SWE Can Provide Earlier SOS Diagnosis Compared to Clinical Criteria.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 2

~390

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