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The study will be evaluating the efficacy and safety of a contrast drug in pediatric renal ultrasound.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contrast | Other | All subjects will be recruited into this arm. All subjects will receive 0.03 ml/kg IV sulfur hexafluoride type-a lipid microspheres one time, unless a second, adjusted dose is necessary. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulfur hexafluoride type-a lipid microspheres | Drug | Used as a contrast to enhance renal ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visualization of Renal Scars Compared to Previous Imaging | The study will evaluate the contrast agent's ability to enable the ultrasound to produce adequate images of the kidneys as compared to the subject's previous renal imaging. This outcome will be measured in percentage of scars visualized by other imaging methods that were detected by using the contrast agent. | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events Related to the Study Drug. | The study will evaluate how many people experience adverse events, specifically the two most common effects (headache and nausea), during the study or during the week following the study. | 1 week |
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Inclusion Criteria:
Includes healthy volunteers
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Hains, M.D. | University of Tennessee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tennessee Health Science Center | Memphis | Tennessee | 38013 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Contrast | All subjects will be recruited into this arm. All subjects will receive 0.03 ml/kg IV sulfur hexafluoride type-a lipid microspheres one time, unless a second, adjusted dose is necessary. Sulfur hexafluoride type-a lipid microspheres: Used as a contrast to enhance renal ultrasound |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Contrast | All subjects will be recruited into this arm. All subjects will receive 0.03 ml/kg IV sulfur hexafluoride type-a lipid microspheres one time, unless a second, adjusted dose is necessary. Sulfur hexafluoride type-a lipid microspheres: Used as a contrast to enhance renal ultrasound |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visualization of Renal Scars Compared to Previous Imaging | The study will evaluate the contrast agent's ability to enable the ultrasound to produce adequate images of the kidneys as compared to the subject's previous renal imaging. This outcome will be measured in percentage of scars visualized by other imaging methods that were detected by using the contrast agent. | In addition to the 7 patients analyzed, 3 participants were excluded from this analysis because they did not have previous scars to analyze. | Posted | Number | Percentage of previous scars visualized | 1 hour |
|
1 week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Contrast | All subjects will be recruited into this arm. All subjects will receive 0.03 ml/kg IV sulfur hexafluoride type-a lipid microspheres one time, unless a second, adjusted dose is necessary. Sulfur hexafluoride type-a lipid microspheres: Used as a contrast to enhance renal ultrasound |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild Headache | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Hains | University of Tennessee Health Science Center | 9012874876 | dhains@uthsc.edu |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D014718 | Vesico-Ureteral Reflux |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
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| Secondary | Number of Participants With Adverse Events Related to the Study Drug. | The study will evaluate how many people experience adverse events, specifically the two most common effects (headache and nausea), during the study or during the week following the study. | Posted | Number | participants | 1 week |
|
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| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |