Using Ultrasound Elastography to Predict Development of SOS

NCT02483481 | Completed Results FDA Device

• 1 other identifier: IRB # 15060244
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Sinusoidal obstruction syndrome (SOS) is a potentially fatal hepatic veno-occlusive disease-affecting children following bone marrow transplantation (BMT). SOS most likely develops secondary to sinusoidal endothelial damage and subsequent obstruction. The disease can be separated into mild, moderate, and severe forms; almost all patients diagnosed with severe SOS will die from this disease. Children with severe SOS suffer from multi-organ failure with signs and symptoms of portal hypertension (ascites, varices, edema), renal and respiratory failure . Although these children may be few and far between, the mere severity of the disease process and awful prognosis factors are valid reasons for more medical attention. SOS is usually diagnosed via clinical criteria and, despite available prophylaxis and treatment, children continue to die from this devastating disease. Quantitative shear wave ultrasound elastography with acoustic force radiation imaging is an emerging technology that uses ultrasound pressure waves to provide an estimate of tissue stiffness. This technique is promising for pediatric imaging because it is portable, quick to perform, relatively low cost and involves no ionizing radiation. Acoustic force radiation imaging and ultrasound elastography does not have any increased risks over conventional ultrasound imaging.

Conditions

Sinusoidal Obstruction Syndrome; Complications of Bone Marrow Transplant

Keywords

sinusoidal obstruction syndrome; ultrasound elastography; bone marrow transplant

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity of US for VOD/SOS

  within 100 days of bone marrow transplant

Secondary Outcomes (1)

• Severity of SOS

  within 100 days of bone marrow transplant

Study Arms (1)

Shear Wave Ultrasound Elastography

OTHER

Diagnostic Test: shear wave ultrasound elastography

Interventions

shear wave ultrasound elastography DIAGNOSTIC_TEST

shear wave ultrasound elastography

Shear Wave Ultrasound Elastography

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All patients who are admitted for BMT from the date of study approval until patient accrual is met.

You may not qualify if:

• BMT patients who do not end up undergoing transplant during that admission. BMT patients who do not receive any abdominal ultrasounds post transplantation BMT patients who do not consent to the study.

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Related Publications (20)

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  PMID: 29335626 RESULT

MeSH Terms

Conditions

Hepatic Veno-Occlusive Disease

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Sherwin Chan
• Organization: Children's Mercy Kansas City

sschan@cmh.edu

816-234-3273

Study Officials

• Sherwin Chan, MD, PhD

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: June 29, 2015
• Study Start: August 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 14, 2024
• Results First Posted: February 14, 2024

Record last verified: 2024-01

Locations

US (1)