Diffusion Tensor Imaging in Predicting Development of Chemotherapy Induced Peripheral Neuropathy in Patients With Breast Cancer (CIPN)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluating the Role of Diffusion Tensor Imaging in Predicting Development of Chemotherapy Induced Peripheral Neuropathy in Patients With Breast Cancer

Conditions
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Breast Carcinoma, Breast Cancer, Neuropathy;Peripheral, Neuropathy

Intervention / Treatment
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* Procedure: Diffusion Tensor Imaging
* Other: Laboratory Biomarker Analysis
* Procedure: Magnetic Resonance Imaging
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (non-enhanced MRI using MRN and DTI)<br>Patients undergo non-enhanced MRI of both lower extremities using MRN and DTI prior to initiation and after completion of standard of care chemotherapy. | Procedure: Diffusion Tensor Imaging<br>* Undergo non-enhanced MRI using MRN and DTI<br>* Other names: DTI;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Procedure: Magnetic Resonance Imaging<br>* Undergo non-enhanced MRI using MRN and DTI<br>* Other names: Nuclear Magnetic Resonance Imaging;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, diffusion, tensor, imaging, chemotherapy, peripheral neuropathy, breast cancer, Magnetic Resonance Imaging, Diffusion Tensor Imaging