Using Ultrasound Elastography to Predict Development of Hepatic Sinusoidal Obstruction Syndrome

Description

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).

Conditions

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

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Study Details

Study overview

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).

Using Ultrasound Elastography to Predict Development of Hepatic Sinusoidal Obstruction Syndrome

Using Ultrasound Elastography to Predict Development of Hepatic Sinusoidal Obstruction Syndrome

Condition
Bone Marrow Transplant Complications
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94143

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Kansas City

Children's Mercy, Kansas City, Missouri, United States, 64108

Durham

Duke University, Durham, North Carolina, United States, 27705

Cleveland

University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States, 44106

Columbus

Nationwide Children's Hospital, Columbus, Ohio, United States, 43205

Memphis

St. Jude Children's Research Hospital, Memphis, Tennessee, United States, 38105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

1 Month to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's Mercy Hospital Kansas City,

Sherwin S Chan, MD, PhD, PRINCIPAL_INVESTIGATOR, Children's Mercy Hospital Kansas City

Study Record Dates

2027-06-30