Diffusion Tensor Imaging in Predicting Development of Chemotherapy Induced Peripheral Neuropathy in Patients With Breast Cancer (CIPN)
NCT ID: NCT03365895
Last Updated: 2020-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
17 participants
INTERVENTIONAL
2017-08-11
2020-10-02
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (non-enhanced MRI using MRN and DTI)
Patients undergo non-enhanced MRI of both lower extremities using MRN and DTI prior to initiation and after completion of standard of care chemotherapy.
Diffusion Tensor Imaging
Undergo non-enhanced MRI using MRN and DTI
Laboratory Biomarker Analysis
Correlative studies
Magnetic Resonance Imaging
Undergo non-enhanced MRI using MRN and DTI
Questionnaire Administration
Ancillary studies
Interventions
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Diffusion Tensor Imaging
Undergo non-enhanced MRI using MRN and DTI
Laboratory Biomarker Analysis
Correlative studies
Magnetic Resonance Imaging
Undergo non-enhanced MRI using MRN and DTI
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Arizona
OTHER
Responsible Party
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Principal Investigators
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Pavani Chalasani, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
The University of Arizona Cancer Center
Lana Gimber, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
The University of Arizona Cancer Center
Locations
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The University of Arizona Cancer Center
Tucson, Arizona, United States
Countries
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Other Identifiers
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NCI-2017-01413
Identifier Type: REGISTRY
Identifier Source: secondary_id
CIPN
Identifier Type: -
Identifier Source: secondary_id
1707634514
Identifier Type: OTHER
Identifier Source: secondary_id
1707634514
Identifier Type: -
Identifier Source: org_study_id