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| ID | Type | Description | Link |
|---|---|---|---|
| WF-01115 | Other Identifier | NCI |
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Funding Issues
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The overall of this proposal is to test in community hospitals the utility of a 10-min magnetic resonance imaging (MRI) scan protocol combined with proprietary image analysis algorithms for detecting early cardiovascular (CV) injury during receipt of chemotherapy for breast cancer (BrC) and lymphoma. This technology provides health-care delivery systems with a time-efficient method to identify those at risk of a future CV event so that prevention can be implemented to prolong survival and reduce morbidity in cancer survivors.
While recent research indicates that conventional MRI, advanced echocardiography (global longitudinal strain and 3D) and serum biomarkers can detect CV injury early after receipt of Chemotherapy, these methods require lengthy and difficult examinations that are not routinely executed in community hospitals where the majority of patients with BrC & lymphoma are treated. Yet, 1-month deteriorations in traditional 45-min MRI measures are known to forecast 6-month subclinical deteriorations in left ventricular ejection fraction (LVEF) that are associated with CV events. At the same time, new observational data indicate therapy with HMG-CoA reductase inhibitors/statins administered early during receipt of Chemotherapy may prevent subsequent cardiac dysfunction and CV events. Our MRI fast scanning techniques remedy these community hospital implementation obstacles.
In this proposal, the investigators propose to test the utility of these fast scans within an existing funded randomized clinical trial R01HL118740 of generic atorvastatin that is researching methods to prevent cardiotoxicity in patients treated with Chemotherapy for BrC and lymphoma (taking advantage of significant existing clinical trial resources). This study allows us to address our over-arching goal: to determine the optimal implementation (alone or in combination with other tests) of our proprietary MRI processes for forecasting CV injury in patients treated with Chemotherapy in community hospitals through performance of a Phase II comparative effectiveness study within an ongoing clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fast MRI | Other | All patients who agree to participate in this study will have a 10 minute fast MRI scan and Baseline and 6 month time periods. The fast MRI will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fast MRI | Diagnostic Test | The fast MRI is a 10 minute MRI scan that will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Ejection Fraction (LVEF) at Baseline, 2 Month Using Fast MRI, and 6 Months | To compare baseline, 2-month (using Fast MRI), and 6 month measures in left ventricular (LV) ejection fraction | Baseline, 2 months, and 6 months |
| End Diastolic Volume (EDV) at Baseline, 2 Month, and 6 Months | To compare baseline, 2-month (using Fast MRI), and 6 month measures in end Diastolic Volume (EDV) | Baseline, 2 months, and 6 months |
| End Systolic Volume (ESV) at Baseline, 2 Month, and 6 Months | To compare baseline, 2-month (using Fast MRI), and 6 month measures in end Systolic Volume (ESV) | Baseline, 2 months, and 6 months |
| Pulse Wave Velocity (PWV) at Baseline and 6 Months | To compare baseline and 6 month measures in pulse wave velocity (PWV) | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Ejection Fraction (LVEF): Comparison of Magnetic Resonance Imaging (MRI) With Echocardiogram (ECHO) at Baseline | To compare Magnetic Resonance Imaging (MRI) metric of Left Ventricular Ejection Fraction (LVEF) with Echocardiogram (ECHO) at baseline | Baseline |
| End Diastolic Volume (EDV): Compare Magnetic Resonance Imaging (MRI) With Echocardiogram (ECHO) at Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Algorithmic Modeling | To use exploratory algorithmic modeling to obtain optimal strategies for determining the combination of metrics (10-min MR, ECHO, serum biomarkers) at 2-months that predict the 6-month post Chemotherapy deteriorations in cardiovascular function. | Baseline to 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Hundley, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fast MRI | All patients who agree to participate in this study will have a 10 minute fast MRI scan and Baseline and 6 month time periods. The fast MRI will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment. Fast MRI: The fast MRI is a 10 minute MRI scan that will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Same as total enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | Fast MRI | All patients who agree to participate in this study will have a 10 minute fast MRI scan and Baseline and 6 month time periods. The fast MRI will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment. Fast MRI: The fast MRI is a 10 minute MRI scan that will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Left Ventricular Ejection Fraction (LVEF) at Baseline, 2 Month Using Fast MRI, and 6 Months | To compare baseline, 2-month (using Fast MRI), and 6 month measures in left ventricular (LV) ejection fraction | Only 5 received MRI at baseline, 4 at 2 months using Fast MRI, and 3 at 6 months. | Posted | Mean | Standard Deviation | percentage of fluid ejected | Baseline, 2 months, and 6 months |
|
From time of signed informed consent to 30 days post study completion for each participant. Study completion was approximately 6 months.
Grades 1, 2, and 3 expected (solicited) and unexpected (unsolicited) adverse events (AE)s that meet the above definition for an AE and are only definitely related, possibly related or probably related to this study intervention should be reported using the Toxicity Assessment Sheet. Hospitalizations that are scheduled for routine treatments and procedures unrelated to study intervention do not need to be reported. All toxicities are graded using CTCAE v4.03.
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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 | Fast MRI | All patients who agree to participate in this study will have a 10 minute fast MRI scan and Baseline and 6 month time periods. The fast MRI will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment. Fast MRI: The fast MRI is a 10 minute MRI scan that will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Infections and infestations | Non-systematic Assessment |
Early termination leading to small number of subject analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregory Hundley, MD | Wake Forest University Health Sciences | 336-716-0607 | ghundley@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 28, 2016 | Oct 16, 2018 | Prot_SAP_000.pdf |
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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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To compare magnetic resonance imaging (MRI) metric of End Diastolic Volume (EDV) with echocardiogram (ECHO) at baseline |
| Baseline |
| End Systolic Volume (ESV): Compare Magnetic Resonance Imaging (MRI) With Echocardiogram (ECHO) at Baseline | To compare magnetic resonance imaging (MRI) metric of End Systolic Volume (ESV) with echocardiogram (ECHO) at baseline | Baseline |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Left Ventricular Ejection Fraction (LVEF) | 1 patient did not receive baseline MRI | Mean | Standard Deviation | percentage of fluid expelled |
|
| End Diastolic Volume (EDV) - Magnetic Resonance Imaging (MRI) | 1 patient did not receive baseline MRI | Mean | Standard Deviation | mL |
|
| End Systolic Volume (ESV) - Magnetic Resonance Imaging (MRI) | 1 patient did not receive baseline MRI | Mean | Standard Deviation | mL |
|
| Pulse Wave Velocity (PWV) - Magnetic Resonance Imaging (MRI) | 1 patient did not receive baseline MRI | Mean | Standard Deviation | meters/sec |
|
| Left Ventricular Ejection Fraction (LVEF) - Echocardiogram (ECHO) | Mean | Standard Deviation | percentage of fluid expelled |
|
| End Diastolic Volume (EDV) - Echocardiogram (ECHO) | Mean | Standard Deviation | mL |
|
| End Systolic Volume (ESV) - Echocardiogram (ECHO) | Mean | Standard Deviation | mL |
|
|
|
|
| Primary | End Diastolic Volume (EDV) at Baseline, 2 Month, and 6 Months | To compare baseline, 2-month (using Fast MRI), and 6 month measures in end Diastolic Volume (EDV) | Only 5 received MRI at baseline, 4 at 2 months using Fast MRI, and 3 at 6 months. | Posted | Mean | Standard Deviation | mL | Baseline, 2 months, and 6 months |
|
|
|
|
| Primary | End Systolic Volume (ESV) at Baseline, 2 Month, and 6 Months | To compare baseline, 2-month (using Fast MRI), and 6 month measures in end Systolic Volume (ESV) | Only 5 received MRI at baseline, 4 at 2 months using Fast MRI, and 3 at 6 months. | Posted | Mean | Standard Deviation | mL | Baseline, 2 months, and 6 months |
|
|
|
|
| Primary | Pulse Wave Velocity (PWV) at Baseline and 6 Months | To compare baseline and 6 month measures in pulse wave velocity (PWV) | Only 5 received MRI at baseline and 3 at 6 months. | Posted | Mean | Standard Deviation | Meters/sec | Baseline and 6 months |
|
|
|
|
| Secondary | Left Ventricular Ejection Fraction (LVEF): Comparison of Magnetic Resonance Imaging (MRI) With Echocardiogram (ECHO) at Baseline | To compare Magnetic Resonance Imaging (MRI) metric of Left Ventricular Ejection Fraction (LVEF) with Echocardiogram (ECHO) at baseline | All 6 participants that received both an ECHO. Only 5 had an MRI at baseline | Posted | Mean | Standard Deviation | percentage of fluid expelled | Baseline |
|
|
|
| Secondary | End Diastolic Volume (EDV): Compare Magnetic Resonance Imaging (MRI) With Echocardiogram (ECHO) at Baseline | To compare magnetic resonance imaging (MRI) metric of End Diastolic Volume (EDV) with echocardiogram (ECHO) at baseline | All 6 participants that received both an ECHO. Only 5 had an MRI at baseline | Posted | Mean | Standard Deviation | mL | Baseline |
|
|
|
| Secondary | End Systolic Volume (ESV): Compare Magnetic Resonance Imaging (MRI) With Echocardiogram (ECHO) at Baseline | To compare magnetic resonance imaging (MRI) metric of End Systolic Volume (ESV) with echocardiogram (ECHO) at baseline | All 6 participants that received both an ECHO. Only 5 had an MRI at baseline | Posted | Mean | Standard Deviation | mL | Baseline |
|
|
|
| Other Pre-specified | Exploratory Algorithmic Modeling | To use exploratory algorithmic modeling to obtain optimal strategies for determining the combination of metrics (10-min MR, ECHO, serum biomarkers) at 2-months that predict the 6-month post Chemotherapy deteriorations in cardiovascular function. | Not Posted | Baseline to 6 months | Participants |
| 0 |
| 6 |
| 0 |
| 6 |
| 1 |
| 6 |
| Headache | Nervous system disorders | Non-systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
|
| Pearson Correlation Coefficient |
| 0.1486 |
| Pearson Correlation Coefficient |
| 0.97287 |
| 2-Sided |
| Other |
Pearson Correlation Coefficient |
|
| Pearson Correlation Coefficient |
| 0.0497 |
| Pearson Correlation Coefficient |
| 0.99696 |
| 2-Sided |
| Other |
Pearson Correlation Coefficient |
|
|
|
|