Ultrasound Elastography to Predict Development of SOS
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03858530|
Recruitment Status : Active, not recruiting
First Posted : February 28, 2019
Last Update Posted : June 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Bone Marrow Transplant Complications Sinusoidal Obstruction Syndrome Veno-occlusive Disease Stem Cell Transplant Complications||Diagnostic Test: Ultrasound Examination||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Using Ultrasound Elastography to Predict Development of Sinusoidal Obstruction Syndrome|
|Actual Study Start Date :||May 1, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||June 30, 2021|
Experimental: All Patients Enrolled
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.
Diagnostic Test: Ultrasound Examination
Grayscale ultrasound, Doppler ultrasound, ultrasound elastography with or without ultrasound intravenous contrast will be performed.
- SWE Accuracy for Diagnosing SOS [ Time Frame: 100 days post transplant ]Determining accuracy of shear wave ultrasound elastography (SWE) for diagnosis of sinusoidal obstruction syndrome (SOS) compared to diagnosis and severity grading using the European Bone Marrow Consoritium (EBMT) clinical criteria.
- Evaluate SWE Accuracy for Severity Grading [ Time Frame: 100 days post transplant ]Evaluate the accuracy of SWE for grading severity of SOS severity compared to severity grading according EBMT clinical criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858530
|United States, Missouri|
|Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|
|Principal Investigator:||Shewin Chan, MD, PhD||Children's Mercy Hospital Kansas City|