Using Ultrasound Elastography to Predict Development of Hepatic Sinusoidal Obstruction Syndrome

Launched by CHILDREN'S MERCY HOSPITAL KANSAS CITY · Mar 4, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how a special ultrasound technique called elastography can help predict the development of a condition known as Hepatic Sinusoidal Obstruction Syndrome (SOS) in patients who are receiving bone marrow transplants. The goal is to identify patients at different risk levels for SOS, which can be a serious complication after such transplants. By using this ultrasound method, researchers hope to find a reliable way to determine who might be at risk and how quickly SOS might develop after treatment.

To participate in the study, patients must be between 1 month and 99 years old and undergoing certain types of high-intensity chemotherapy before their transplant. This includes patients who have specific medical conditions that put them at higher risk for SOS. Participants will receive ultrasound exams to assess their liver health, and the study will help improve understanding of how to better manage and treat patients at risk for SOS. It's important to note that certain individuals, such as pregnant women or those who cannot hold still for the ultrasound, may not be able to participate.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• • OR
• • 2. Any patient who has a myeloablative conditioning regimen (as defined by the local HCT 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 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
• Exclusion Criteria:
• • 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