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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
Sponsor:
Information provided by (Responsible Party):
Children's Mercy Hospital Kansas City

Brief Summary:
The long-term goal of our research is to accurately identify SOS patients who would benefit from defibrotide treatment using US SWE. The overall objective of this study is to validate SWE as an early diagnostic marker for SOS. Our central hypothesis is that SWE changes will precede clinical and conventional US diagnostic criteria for SOS. Our hypothesis has been formulated on the basis of our own preliminary data. The investigators completed the first prospective cohort trial demonstrating that US SWE provides SOS diagnosis (80% sensitivity and 67% specificity) nine days earlier than current clinical criteria. SWE is widely available, has no known side effects, and is easy to learn and interpret. Our study enrolled 25 high-risk BMT patients over 18 months (five with SOS and two with severe SOS). More data is needed to determine the optimal window for testing to balance between improved test characteristics and early detection of disease. The investigators propose conducting a prospective cohort study with 80 additional patients, 12 of which will likely develop SOS (including four with severe SOS) to optimize SWE timing. This study will increase the confidence in the findings from our preliminary study and allow us to test SWE against newly published clinical criteria. The rationale for the proposed research is that, if SWE can diagnose SOS earlier than clinical criteria, then SWE can guide early initiation of SOS treatment.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children and adults, ages 1 month through 21 years who are undergoing allogenic or autologous myeloablative stem cell transplant.

Exclusion Criteria:

  • Any other medical or social condition that in the opinion of the investigator would make them unsuitable to participate.
  • Inability to properly image patient by ultrasound (e.g. uncooperative)

Information from the National Library of Medicine

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


Locations
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United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
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Principal Investigator: Shewin Chan, MD, PhD Children's Mercy Hospital Kansas City
Additional Information:
Publications:

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Responsible Party: Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT03858530    
Other Study ID Numbers: 17110684
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Children's Mercy Hospital Kansas City:
Ultrasound elastography
Additional relevant MeSH terms:
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Hepatic Veno-Occlusive Disease
Syndrome
Disease
Pathologic Processes
Liver Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases