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Using Ultrasound Elastography to Predict Development of Hepatic Sinusoidal Obstruction Syndrome

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ClinicalTrials.gov Identifier: NCT03865589
Recruitment Status : Recruiting
First Posted : March 7, 2019
Last Update Posted : September 26, 2022
Sponsor:
Collaborators:
Jazz Pharmaceuticals
Nationwide Children's Hospital
Dana-Farber Cancer Institute
University of California, San Francisco
University Hospitals Cleveland Medical Center
Information provided by (Responsible Party):
Sherwin Chan, Children's Mercy Hospital Kansas City

Brief Summary:
To perform an receiver operating characteristic (ROC) analysis, define a threshold and quantify the sensitivity and specificity of US SWE for risk stratification of patients into three categories as defined by the European Bone Marrow Transplant (EBMT) adult and pediatric criteria: no sinusoidal obstruction syndrome (SOS), mild to moderate SOS, and severe to very severe SOS. Secondarily, the investigators would also like to quantify the temporal relationship between US SWE changes and SOS diagnosis according to various clinical criteria (Modified Seattle, Baltimore, EBMT consortium).

Condition or disease Intervention/treatment Phase
Bone Marrow Transplant Complications Sinusoidal Obstruction Syndrome Veno Occlusive Disease, Hepatic Stem Cell Transplant Complications Diagnostic Test: Ultrasound Elastography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All patients undergoing myeloblative conditioning regimen as part of hematopoietic cell transplant will be consecutively studied
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Using Ultrasound Elastography to Predict Development of Hepatic Sinusoidal Obstruction Syndrome
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients Undergoing HCT
All patients enrolled will undergo US SWE at specific time points as outlined in the protocol based on disease course.
Diagnostic Test: Ultrasound Elastography
Ultrasound shear wave elastography




Primary Outcome Measures :
  1. Define Sensitivity and Specificity Threshold for US SWE Risk [ Time Frame: 100 days post transplant ]
    To define a threshold and quantify the sensitivity and specificity of US SWE for risk stratification of patients into three categories as defined by the EBMTC adult and pediatric criteria: no SOS, mild to moderate SOS, and severe to very severe SOS


Secondary Outcome Measures :
  1. Quantify Temporal Relationship between SWE and SOS and Modified Seattle Criteria [ Time Frame: 100 days post transplant ]
    Quantify the temporal relationship between US SWE changes and SOS diagnosis according to Modified Seattle Criteria

  2. Quantify Temporal Relationship between SWE and SOS and Baltimore Criteria [ Time Frame: 100 days post transplant ]
    Quantify the temporal relationship between US SWE changes and SOS diagnosis according to various clinical criteria Baltimore Criteria

  3. Quantify Temporal Relationship between SWE and SOS and EBMT Consortium [ Time Frame: 100 days post transplant ]
    Quantify the temporal relationship between US SWE changes and SOS diagnosis according to EBMT consortium.



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Ages Eligible for Study:   1 Month to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any patient undergoing a myeloablative conditioning regimen for HCT between 4/1/2019 and 12/31/2120 defined as one of the following:

    • TBI >= 1200 cGy (fractionated)
    • Cyclophosphamide + TBI (> 500 cGy (single) or > 800cGy (fractionated))
    • Cyclophosphamide + Etoposide + TBI (> 500 cGy (single) or > 800 cGy (fractionated))
    • Cyclophosphamide + Thiotepa + TBI (> 500 cGy (single) or > 800 cGy (fractionated))
    • Busulfan (Total dose > 7.2 mg/kg IV or >9.0mg/kg orally) + Cyclophosphamide
    • Busulfan (Total dose >7.2 mg/kg IV or >9.0 mg/kg orally) + Melphalan
    • Busulfan (Total dose >7.2 mg/kg IV or >9.0 mg/kg orally) + Thiotepa
    • NOTE: Busulfan cumulative plasma AUC of >75 mg/L per hour or >18270 microMolar per minute could be used in the preceding criteria in lieu of the mg/kg doses.

OR

2. Any patient who has a myeloablative conditioning regimen (as defined by the local HSCT team) that includes sirolimus and tacrolimus for GVHD prophylaxis.

OR

3. Any patient who is high risk for SOS irrespective of conditioning regimen: Neuroblastoma, HLH, Osteopetrosis, Thalassemia, treatment with inotuzumab or gemtuzumab within 3 months prior to HSCT admission, 2nd HSCT if it is myeloablative and within 6 months of prior, iron overload, steatohepatitis, active inflammatory or infection hepatitis or any other condition which puts the patient at a higher risk of developing SOS.

Exclusion Criteria:

  • Any patient who has contraindication to US SWE (e.g. unable to hold still)

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): NCT03865589


Contacts
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Contact: Amie Robinson, BSRT,CCRP 8163028311 alrobinson@cmh.edu
Contact: Maura Sien, RN, BSN 8163026065 mesien@cmh.edu

Locations
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United States, Missouri
Amie Robinson Recruiting
Kansas City, Missouri, United States, 64108
Contact: Amie Robinson    816-302-8311    alrobinson@cmh.edu   
Contact: Maura Sien       mesien@cmh.edu   
Principal Investigator: Sherwin S Chan, MD, PhD         
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Jazz Pharmaceuticals
Nationwide Children's Hospital
Dana-Farber Cancer Institute
University of California, San Francisco
University Hospitals Cleveland Medical Center
Investigators
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Principal Investigator: Sherwin S Chan, MD, PhD Children's Mercy Hospital Kansas City
Publications:
B. Cozadd, paper presented at the 36th Annual J.P. Morgan Annual Healthcare Conference, San Francisco, California, January 8, 2018 2018
Z. X. D'Souza A. (Available at: http://www.cibmtr.org, 2016), vol. 2017
P. Negrin RS; Bonis, M. Nelson J Chao, Ed. (www.uptodate.com, 2017), vol. 2017
The Medical Letter. (https://secure.medicalletter.org/w1503c, 2016), vol. 2017.

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Responsible Party: Sherwin Chan, Physician, MD, PhD, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT03865589    
Other Study ID Numbers: STUDY0000548
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: September 26, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sherwin Chan, 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