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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-01413 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CIPN | |||
| 1707634514 | Other Identifier | University of Arizona | |
| P30CA023074 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot early phase I trial studies how well diffusion tensor imaging works in predicting development of chemotherapy induced peripheral neuropathy in patients with breast cancer. Diffusion tensor imaging may help to get better pictures of the nerves of feet and lower legs before and after chemotherapy treatment and may help to predict the risk of developing peripheral neuropathy.
PRIMARY OBJECTIVES:
I. To assess the changes in the fractional anisotropy (FA) and apparent diffusion coefficient (ADC) values of the lower extremity nerves by diffusion tensor imaging (DTI) before initiation and after completion of taxane chemotherapy in patients with breast cancer.
SECONDARY OBJECTIVES:
I. Establish normal and abnormal FA and ADC values of the lower extremity nerves.
II. Evaluate relationship of DTI findings of chemotherapy induced peripheral neuropathy (CIPN) with self-reported Patient Neurotoxicity Questionnaire (PNQ) and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-neurotoxicity questionnaire (FACT-GOT-NTX) questionnaires.
III. Assess inter-reader variability in measuring FA and ADC values.
OUTLINE:
Patients undergo non-enhanced magnetic resonance imaging (MRI) of both lower extremities using magnetic resonance neurography (MRN) and DTI prior to initiation and after completion of standard of care chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (non-enhanced MRI using MRN and DTI) | Experimental | Patients undergo non-enhanced MRI of both lower extremities using MRN and DTI prior to initiation and after completion of standard of care chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diffusion Tensor Imaging | Procedure | Undergo non-enhanced MRI using MRN and DTI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in quantitative fractional anisotropy (FA) of the lower extremity nerves by diffusion tensor imaging (DTI) | The quantitative DTI parameters measured before the initiation of and after completion of chemotherapy will be compared and used to calculate the degree of change. Descriptive statistics (with confidence interval [CI]) will be used for the current sample size. | Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy) |
| Changes in apparent diffusion coefficient (ADC) of the lower extremity nerves by diffusion tensor imaging (DTI) | The quantitative DTI parameters measured before the initiation of and after completion of chemotherapy will be compared and used to calculate the degree of change. Descriptive statistics (with confidence interval [CI]) will be used for the current sample size. | Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy) |
| Measure | Description | Time Frame |
|---|---|---|
| Inter-reader variability and reproducibility in measuring fractional anisotropy (FA) by diffusion tensor imaging (DTI) | Inter-reader agreement in measuring the quantitative DTI measurements will be assessed by percentage agreement. | Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pavani Chalasani, MD, MPH | The University of Arizona Cancer Center | Principal Investigator |
| Lana Gimber, MD, MPH | The University of Arizona Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Arizona Cancer Center | Tucson | Arizona | 85724 | United States |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Magnetic Resonance Imaging | Procedure | Undergo non-enhanced MRI using MRN and DTI |
|
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| Questionnaire Administration | Other | Ancillary studies |
|
| Inter-reader variability and reproducibility in measuring apparent diffusion coefficient (ADC) by diffusion tensor imaging (DTI) | Inter-reader agreement in measuring the quantitative DTI measurements will be assessed by percentage agreement. | Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy) |
| Normal fractional anisotropy (FA) values of lower extremity nerves | The normal FA and ADC values of the lower extremity nerves will be estimated using mean FA and ADC values with 95% CIs for before and after chemotherapy will be calculated. | Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy) |
| Normal apparent diffusion coefficient (ADC) values of lower extremity nerves | The normal FA and ADC values of the lower extremity nerves will be estimated using mean FA and ADC values with 95% CIs for before and after chemotherapy will be calculated. | Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy) |
| Peripheral neuropathy severity questionnaires | The correlation between FA and ADC values with the self-reported Patient Neurotoxicity Questionnaire and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-neurotoxicity questionnaire will be evaluated using Pearson or spearman correlation coefficient. | Pre-Treatment (0-30 days prior to receiving first chemotherapy) and on last day of chemotherapy |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009443 | Neuritis |
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D056324 | Diffusion Tensor Imaging |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D059906 | Neuroimaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D038524 | Diffusion Magnetic Resonance Imaging |
| D008279 | Magnetic Resonance Imaging |
| D014054 | Tomography |
| D003943 | Diagnostic Techniques, Neurological |
| D008919 | Investigative Techniques |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
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