NCT03365895

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Carcinoma
• Breast Cancer
• Neuropathy;Peripheral
• Neuropathy

Interventions

Type	Name	Description
PROCEDURE	Diffusion Tensor Imaging	Undergo non-enhanced MRI using MRN and DTI
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Magnetic Resonance Imaging	Undergo non-enhanced MRI using MRN and DTI
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2017-08-11
• Primary completion: 2019-09-30
• Completion: 2020-10-02
• First posted: 2017-12-07
• Last updated: 2020-11-19

Locations

1 site across 1 country: United States