A Phase 1/2 interventional study of Lumason in Abdominal Injury, sponsored by David Mooney. Terminated at 8 sites in United States. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-06-11.
Sponsored by David Mooney · Phase 1/2, Interventional, and Diagnostic
This study proposes to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) in diagnosing abdominal solid organ injuries in pediatric patients. 146 subjects will be enrolled across approximately 8 sites in the US. All subjects will have had a Computerized Tomography (CT) scan as part of standard of care, confirming at least one solid organ abdominal injury. All subjects will have an abdominal ultrasound without contrast, followed by a contrast-enhanced ultrasound using the contrast agent Lumason. Ultrasound and contrast-enhanced ultrasound results will be compared to the CT scan results. The study procedures will take place within 48 hours of injury.
This is an interventional study proposes to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) in diagnosing abdominal solid organ injuries in pediatric patients. 146 subjects will be enrolled across approximately 8 sites in the US. All subjects will have had a Computerized Tomography (CT) scan as part of standard of care, confirming at least one solid organ abdominal injury. All subjects will have an abdominal ultrasound without contrast, followed by a contrast-enhanced ultrasound using the contrast agent Lumason. Ultrasound and contrast-enhanced ultrasound results will be compared to the CT scan results. The study procedures will take place within 48 hours of injury. At conclusion of enrollment of all subjects a centralized review of CT vs. CEUS will occur to compare to real time readings.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's enrollment of 74 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →David Mooney is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All subjects will have an abdominal non-contrast ultrasound performed. Lumason will then be administered at a dose of 0.03mL/kg up to a maximum dose of 2.4mL and a contrast-enhanced ultrasound will be performed. The dose will be given twice, for a total maximum dose per subject of 4.8mL
Drug: Lumason
Lumason will be administered at a dose of 0.03 mL/kg up to a maximum dose of 2.4mL injected into a peripheral intravenous catheter. An abdominal contrast enhanced ultrasound will be performed to look for solid organ injury. The will be given twice during the intervention, for a total maximum dose per subject of 4.8mL.
Also known as: SonoVue
Proportion of Patients for Whom All Organs Identified by CT With Injuries Are Also Identified by CEUS, Regardless of Injury Grade.
During analysis, results of contrast enhanced ultrasound will be compared to results of CT scan that was performed as part of clinical care to determine if the organs identified as injured by CT were also identified as injured by CEUS.
Time frame: At the time the CEUS is performed, within 48 hours of injury.
For Each Organ, the Proportion of Patients for Whom the Organ is Identified by CT and CEUS as Injured (Regardless of Grade).
Results will be categorized by organ and analyzed to determine the percentage of injuries for each organ that were identified by CT that were also identified by CEUS.
Time frame: At the time the CEUS is performed, within 48 hours of injury.
Proportion of Injuries Identified by CEUS Which Are Within 1 Grade of the Injury Identified by CT.
The grade for the severity of the injury as determined by CEUS will be compared to the grade for the severity of the injury as determined by CT scan.
Time frame: At the time the CEUS is performed, within 48 hours of injury.
Proportion of Patients Where the Absence or Presence of Peritoneal Fluid Identified by CT is Also Identified by CEUS.
The presence or absence of peritoneal fluid as determined by CEUS will be compared to the presence or absence of peritoneal fluid as determined by CT scan.
Time frame: At the time the CEUS is performed, within 48 hours of injury.
Proportion of Patients With Agreement Between 'Real-time' and Centralized Interpretation of CEUS Images.
The contrast-enhanced ultrasounds will be re-read by a centralized reviewer and the results compared to those from the real-time reading.
Time frame: At the time the CEUS is performed, within 48 hours of injury.
| Milestone | All Study Participants |
|---|---|
| Started | 74 |
| Completed | 71 |
| Not completed | 3 |
During analysis, results of contrast enhanced ultrasound will be compared to results of CT scan that was performed as part of clinical care to determine if the organs identified as injured by CT were also identified as injured by CEUS.
| Participants | All Study Participants |
|---|---|
| Proportion of Patients for Whom All Organs Identified by CT With Injuries Are Also Identified by CEUS, Regardless of Injury Grade. | 53 |
Results will be categorized by organ and analyzed to determine the percentage of injuries for each organ that were identified by CT that were also identified by CEUS.
| Participants | Liver | Spleen | Right Kidney | Left Kidney | Pancreas |
|---|---|---|---|---|---|
| For Each Organ, the Proportion of Patients for Whom the Organ is Identified by CT and CEUS as Injured (Regardless of Grade). | 16 | 36 | 6 | 9 | 0 |
The grade for the severity of the injury as determined by CEUS will be compared to the grade for the severity of the injury as determined by CT scan.
| Participants | Liver | Spleen | Right Kidney | Left Kidney | Pancreas |
|---|---|---|---|---|---|
| Proportion of Injuries Identified by CEUS Which Are Within 1 Grade of the Injury Identified by CT. | 11 | 34 | 4 | 9 | 0 |
The presence or absence of peritoneal fluid as determined by CEUS will be compared to the presence or absence of peritoneal fluid as determined by CT scan.
| Participants | CT-Fluid | CT-No Fluid |
|---|---|---|
| Proportion of Patients Where the Absence or Presence of Peritoneal Fluid Identified by CT is Also Identified by CEUS. | 42 | 9 |
The contrast-enhanced ultrasounds will be re-read by a centralized reviewer and the results compared to those from the real-time reading.
| percentage of participants | Liver | Spleen | Right Kidney | Left Kidney | Pancreas | All Organs |
|---|---|---|---|---|---|---|
| Proportion of Patients With Agreement Between 'Real-time' and Centralized Interpretation of CEUS Images. | 77.9 | 72.1 | 88.2 | 95.6 | 98.5 | 44.1 |
Collected over Adverse event data was collected from the time of consent until 30 minutes after the second Lumason injection, within 48 hours of the participant's injury.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Study Participants | 0/74 (0%) | 0/74 (0%) | 3/74 (4.1%) |
| Event | All Study Participants |
|---|---|
| Injection Site ReactionSkin and subcutaneous tissue disorders | 1/74 |
| DizzinessNervous system disorders | 1/74 |
| HeadacheNervous system disorders | 1/74 |
| Age, Categorical(Participants) | All Study Participants |
|---|---|
| <=18 years | 74 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 13.3 (8.0 to 17.7) |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 21 |
| Male | 53 |
| Race (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 2 |
| Black or African American | 1 |
| White | 64 |
| More than one race | 3 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| United States | 74 |
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David Mooney