Ultrasound test may spot liver trouble early in transplant patients
NCT ID NCT03865589
First seen Jun 26, 2026 · Last updated Jul 15, 2026 · Updated 3 times
Summary
This study is testing whether a special ultrasound technique, called shear wave elastography, can predict a serious liver complication called sinusoidal obstruction syndrome (SOS) in children and adults receiving bone marrow or stem cell transplants. Researchers will measure liver stiffness with ultrasound before and after transplant to see if changes can identify patients at risk. The goal is to improve early detection and help doctors tailor treatment more quickly.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ultrasound shear wave elastography
- What this could lead to
- If successful, this could provide a non-invasive way to predict liver damage early after transplant, helping doctors intervene sooner.
- What could go wrong
- This is an observational diagnostic study, not a treatment trial. The test may not be accurate enough to change outcomes, and results may not apply to all transplant patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
250 people
The number who actually took part.
- Started
-
Apr 2019
- Finished
-
Dec 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
1 month to 99 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Bone marrow transplant complications are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Children's Mercy
Kansas City, Missouri, 64108, United States
-
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
-
Duke University
Durham, North Carolina, 27705, United States
-
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
-
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
-
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
-
University of California, San Francisco
San Francisco, California, 94143, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can adding methotrexate to steroids tame a dangerous transplant complication?
- Can regional data improve bone marrow transplant results for blood cancers?
- Mouth device aims to keep Sore-Relief rinses where They're needed
- Hidden heart risks in testicular cancer survivors: a closer look at chemotherapy's long shadow
- A bedtime kit for the hospital: can ear plugs and a lightbox help young transplant patients sleep?
- Virtual reality could ease stress of bone marrow transplants