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

University of Arizona

Status: Completed

Conditions: Breast Cancer; Neuropathy;Peripheral; Neuropathy; Breast Carcinoma

Treatments: Other: Questionnaire Administration; Other: Laboratory Biomarker Analysis; Procedure: Diffusion Tensor Imaging; Procedure: Magnetic Resonance Imaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03365895

CIPN

1707634514 (Other Identifier)

NCI-2017-01413 (Registry Identifier)

P30CA023074 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Diagnostic (non-enhanced MRI using MRN and DTI)

Experimental group

Description:

Patients undergo non-enhanced MRI of both lower extremities using MRN and DTI prior to initiation and after completion of standard of care chemotherapy.

Treatment:

Other: Laboratory Biomarker Analysis

Procedure: Magnetic Resonance Imaging

Procedure: Diffusion Tensor Imaging

Other: Questionnaire Administration