Breast Carcinoma, Breast Cancer, Neuropathy;Peripheral, Neuropathy
Conditions
Keywords
diffusion, tensor, imaging, chemotherapy, peripheral neuropathy, breast cancer, MRI, Magnetic Resonance Imaging, Diffusion Tensor Imaging
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREDiffusion Tensor Imaging
Undergo non-enhanced MRI using MRN and DTI
OTHERLaboratory Biomarker Analysis
Correlative studies
PROCEDUREMagnetic Resonance Imaging
Undergo non-enhanced MRI using MRN and DTI
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
University of Arizona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be capable of understanding the investigational nature of the study and all pertinent aspects of the study * Be capable of signing and providing written consent in accordance with institutional and federal guidelines * Have a histologically-confirmed diagnosis of breast cancer * Need to be treated with taxane containing chemotherapy as determined by their treating physician * Be able to undergo magnetic resonance (MR) imaging * Be willing and able to comply with scheduled visits, treatment plan, and MR imaging
Exclusion criteria
* Have non-MRI compatible metallic objects on/in body * Have metallic hardware in the lower extremity which is MR compatible however would create too much artifact for MR examination * Are unable to lay still in the MR scanner for length of examination * Have severe claustrophobia * Have pre-existing peripheral neuropathy from other medical conditions or due to cancer * Have diagnosis of diabetes * Pregnant patients * Prior exposure to neurotoxic chemotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in quantitative fractional anisotropy (FA) of the lower extremity nerves by diffusion tensor imaging (DTI) | Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy) | 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. |
| Changes in apparent diffusion coefficient (ADC) of the lower extremity nerves by diffusion tensor imaging (DTI) | Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Normal fractional anisotropy (FA) values of lower extremity nerves | Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy) | 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. |
| Inter-reader variability and reproducibility in measuring fractional anisotropy (FA) by diffusion tensor imaging (DTI) | Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy) | Inter-reader agreement in measuring the quantitative DTI measurements will be assessed by percentage agreement. |
| Peripheral neuropathy severity questionnaires | Pre-Treatment (0-30 days prior to receiving first chemotherapy) and on last day of chemotherapy | 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. |
| Normal apparent diffusion coefficient (ADC) values of lower extremity nerves | Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy) | 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. |
| Inter-reader variability and reproducibility in measuring apparent diffusion coefficient (ADC) by diffusion tensor imaging (DTI) | Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy) | Inter-reader agreement in measuring the quantitative DTI measurements will be assessed by percentage agreement. |
Countries
United States
Outcome results
None listed