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| ID | Type | Description | Link |
|---|---|---|---|
| 115,576 | Other Identifier | fda |
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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
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The contrast agent Definity® is FDA approved for use as a contrast agent during ultrasound (echocardiography) of the heart. Definity® will be used "off-label" (during ultrasound of the breast) in this study. The administration of Definity® during this study will follow total dose guidelines approved by the FDA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2D US grayscale plus quantitative VCEUS | Other | Patients with breast cancer receiving neoadjuvant chemotherapy will undergo a 2D grayscale imaging followed by quantitative VCEUS imaging:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2D US grayscale plus quantitative VCEUS | Diagnostic Test | This is a pilot study to evaluate quantitative VCEUS imaging for determining early breast cancer response to neoadjuvant chemotherapy, comparing results with volume change on grayscale US and planar CEUS, and correlating imaging findings with pathological response on surgical specimens. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Volume Measure Using Grayscale US | Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters. | Baseline (first visit) |
| VCEUS Perfusion Time to Peak | Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds. | Baseline |
| Tumor Volume Measure Using Grayscale US | Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters. | Week 2 |
| Tumor Volume Measure Using Grayscale US | Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters. | Week 4 |
| Tumor Volume Measure Using Grayscale US | Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters. | 6 months |
| VCEUS Perfusion Time to Peak | Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds. | Week 2 |
| VCEUS Perfusion Time to Peak |
| Measure | Description | Time Frame |
|---|---|---|
| Pathology Residual Tumor | Pathology residual tumor measured in millimeters | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark E Lockhart, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
Recruitment for this study started in June 2015. The primary completion point was reached at July 2016, and study completion July 2016. The study was conducted at the University of Alabama at Birmingham.
A total of 22 patients was planned in this pilot study through the UAB Interdisciplinary Breast Center. However, due to early termination of the study, only six breast cancer patients were enrolled. Each participant received both interventions (2D ultrasound grayscale vs Definity Volume contrast enhanced ultrasound).
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| ID | Title | Description |
|---|---|---|
| FG000 | Evaluation of VCEUS to Determine Response to Chemotherapy | Patients with breast cancer receiving neoadjuvant chemotherapy will undergo 2D grayscale imaging followed by the quantitative VCEUS imaging as follows:
Definity (Perflutren Lipid Microspheres): This is a pilot study to evaluate quantitative VCEUS imaging for determining early breast cancer response to neoadjuvant chemotherapy, comparing results with volume change on grayscale US and planar CEUS, and correlating imaging findings with pathological response on surgical specimens. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Total number of participants is 6. All participants received both interventions.
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| ID | Title | Description |
|---|---|---|
| BG000 | Evaluation of VCEUS to Determine Response to Chemotherapy | Patients with breast cancer receiving neoadjuvant chemotherapy will undergo quantitative VCEUS imaging and 2D grayscale imaging as follows:
Definity (Perflutren Lipid Microspheres): This is a pilot study to evaluate quantitative VCEUS imaging for determining early breast cancer response to neoadjuvant chemotherapy, comparing results with volume change on grayscale US and planar CEUS, and correlating imaging findings with pathological response on surgical specimens. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Tumor Volume Measure Using Grayscale US | Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters. | Posted | Mean | Standard Deviation | millimeters | Baseline (first visit) |
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Adverse events were collected from Baseline through 3 months..
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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 | Definity VCEUS | Patients with breast cancer receiving neoadjuvant chemotherapy will undergo quantitative VCEUS imaging and 2D grayscale imaging as follows:
Definity (Perflutren Lipid Microspheres): This is a pilot study to evaluate quantitative VCEUS imaging for determining early breast cancer response to neoadjuvant chemotherapy, comparing results with volume change on grayscale US and planar CEUS, and correlating imaging findings with pathological response on surgical specimens. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marianne Vetrano | UAB Radiology Research | 205-934-4080 | mvetrano@uabmc.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds. |
| Week 4 |
| VCEUS Perfusion Time to Peak | Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds. | 6 months |
| Participants |
| No |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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| Primary | VCEUS Perfusion Time to Peak | Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds. | 1 subject did not complete this timepoint due to machine down | Posted | Mean | Standard Deviation | seconds | Baseline |
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|
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| Primary | Tumor Volume Measure Using Grayscale US | Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters. | Posted | Mean | Standard Deviation | millimeters | Week 2 |
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|
|
| Primary | Tumor Volume Measure Using Grayscale US | Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters. | Posted | Mean | Standard Deviation | millimeters | Week 4 |
|
|
|
| Primary | Tumor Volume Measure Using Grayscale US | Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters. | Posted | Mean | Standard Deviation | millimeters | 6 months |
|
|
|
| Primary | VCEUS Perfusion Time to Peak | Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds. | Posted | Mean | Standard Deviation | seconds | Week 2 |
|
|
|
| Primary | VCEUS Perfusion Time to Peak | Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds. | Posted | Mean | Standard Deviation | seconds | Week 4 |
|
|
|
| Primary | VCEUS Perfusion Time to Peak | Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds. | Posted | Mean | Standard Deviation | seconds | 6 months |
|
|
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| Secondary | Pathology Residual Tumor | Pathology residual tumor measured in millimeters | Posted | Mean | Standard Deviation | millimeters | 6 months |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
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| D017437 |
| Skin and Connective Tissue Diseases |