Using Ultrasound Elastography to Predict Development of Hepatic Sinusoidal Obstruction Syndrome

Completed · Not applicable

Conditions studied: Bone Marrow Transplant Complications, Sinusoidal Obstruction Syndrome, Veno Occlusive Disease, Hepatic, Stem Cell Transplant Complications

In brief

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).

Key facts

Study ID

NCT03865589

Run by

Children's Mercy Hospital Kansas City

People needed

250

Starts

2019-04-01

Expected to finish

2025-12-31

Last updated by the study team

2026-07-14

Who can join

Age: 0 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Any patient undergoing a myeloablative conditioning regimen for HCT between 3/1/2019 and 12/31/2025 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
• Any patient who has a myeloablative conditioning regimen (as defined by the local HCT team) that includes sirolimus and tacrolimus for GVHD prophylaxis.
• OR
• 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 HCT admission, 2nd HCT 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.
• Subjects aged 1 month through 99 years will be eligible for the study. Patients who receive defibrotide and/or ursodiol for VOD/SOS prophylaxis will also be eligible for the study. At most 175 children (ages 1 month to 18 years) and 175 adults (>18 years old) can be enrolled into the study.
• Inclusion dates: Patients seen between 1/1/2019 and 12/31/2025

You may not qualify if…

• Any patient who has contraindication to ultrasound shear wave elastography (e.g. unable to hold still) Adults unable to consent Pregnant women Prisoners Wards of the state

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Children's Mercy — Kansas City, Missouri, United States
• Duke University — Durham, North Carolina, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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