Trial Outcomes & Findings for Ultrasound Elastography to Predict Development of SOS (NCT NCT03858530)

NCT ID: NCT03858530

Last Updated: 2024-09-04

Results Overview

We performed SWE exams once a week for all of our patients. We looked at when patients met clinical criteria for VOD/SOS and then we looked at the SWE exams that were performed before the clinical diagnosis. If the exam immediately preceding the date of clinical diagnosis crossed the threshold for SWE diagnosis, then a frequency of 7 days was sufficient. If it did not, then testing should be more frequent. If multiple preceding exams were positive by SWE, then the optimal testing frequency could be longer than 7 days.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 21 participants
• Primary outcome timeframe: Once a week through study completion assessed for up to 14 weeks
• Results posted on: 2024-09-04

Participant Flow

Participant milestones

Measure	All Patients Enrolled All patients will undergo limited abdominal US with Doppler and SWE once a week upon admission for conditioning until the patient day +30 BMT or discharge, whichever comes first. Additional ultrasounds will also be performed if SOS is suspected. Ultrasound Examination: Grayscale ultrasound, Doppler ultrasound, ultrasound elastography with or without ultrasound intravenous contrast will be performed.
Overall Study STARTED	21
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ultrasound Elastography to Predict Development of SOS

Baseline characteristics by cohort

Measure	All Patients Enrolled n=21 Participants All patients will undergo limited abdominal US with Doppler and SWE once a week upon admission for conditioning until the patient day +30 BMT or discharge, whichever comes first. Additional ultrasounds will also be performed if SOS is suspected. Ultrasound Examination: Grayscale ultrasound, Doppler ultrasound, ultrasound elastography with or without ultrasound intravenous contrast will be performed.
Age, Categorical <=18 years	20 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

PRIMARY outcome

Timeframe: Once a week through study completion assessed for up to 14 weeks

We performed SWE exams once a week for all of our patients. We looked at when patients met clinical criteria for VOD/SOS and then we looked at the SWE exams that were performed before the clinical diagnosis. If the exam immediately preceding the date of clinical diagnosis crossed the threshold for SWE diagnosis, then a frequency of 7 days was sufficient. If it did not, then testing should be more frequent. If multiple preceding exams were positive by SWE, then the optimal testing frequency could be longer than 7 days.

Outcome measures

Measure	Patients With SOS n=6 Participants Patients who developed SOS during the study period	Patients With Severe and Very Severe SOS Patients who developed severe and very severe SOS during the study
Number of Days Between SWE Exams for VOD/SOS	7 days Interval 7.0 to 7.0	—

SECONDARY outcome

Timeframe: Daily through study completion assessed for up to 100 days

Number of days where SWE became positive before the clinical criteria became positive.

Outcome measures

Measure	Patients With SOS n=6 Participants Patients who developed SOS during the study period	Patients With Severe and Very Severe SOS Patients who developed severe and very severe SOS during the study
Determine if SWE Can Provide Earlier SOS Diagnosis Compared to Clinical Criteria.	3 days Interval 0.0 to 14.0	—

SECONDARY outcome

Timeframe: Weekly through study completion assessed for up to 14 weeks

Outcome measures

Measure	Patients With SOS n=3 Participants Patients who developed SOS during the study period	Patients With Severe and Very Severe SOS n=3 Participants Patients who developed severe and very severe SOS during the study
Difference in Maximum SWE Value in Patients With Severe and Very Severe VOD Compared to Those With Mild and Moderate VOD.	41 percent change from baseline Interval -2.0 to 213.0	79 percent change from baseline Interval 55.0 to 91.0

SECONDARY outcome

Timeframe: Study period

Population: Data was not collected for this outcome variables because we can't get the software to collect this data.

Quantify relative ability to CEUS parameters versus grayscale and Doppler ultrasound.

We will compare sensitivity and specificity of time to peak and mean transit time to grayscale and Doppler ultrasound variables for VOD diagnosis.

Outcome measures

Outcome data not reported

Adverse Events

All Patients Enrolled

Serious events: 0 serious events

Other events: 0 other events

Deaths: 9 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sherwin Chan

Children's Mercy Kansas City

Phone: 816-234-3273

Email: sschan@cmh.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place