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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Breast Carcinoma; Neuropathy; Neuropathy;Peripheral
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Procedure: Diffusion Tensor Imaging; Procedure: Magnetic Resonance Imaging

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • The University of Arizona Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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.

Other: Laboratory Biomarker Analysis; Correlative studies; Other: Questionnaire Administration; Ancillary studies; Procedure: Diffusion Tensor Imaging; Undergo non-enhanced MRI using MRN and DTI; Other Names: DTI; DIFFUSION TENSOR MRI; DT-MRI; Procedure: Magnetic Resonance Imaging; Undergo non-enhanced MRI using MRN and DTI; Other Names: MRI; Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MRI Scan; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Arizona
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Pavani Chalasani, MD, MPH, The University of Arizona Cancer Center; Principal Investigator: Lana Gimber, MD, MPH, The University of Arizona Cancer Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 11, 2017
• Primary Completion (ACTUAL): September 30, 2019
• Study Completion (ACTUAL): October 2, 2020

Study Registration Dates

• First Submitted: November 16, 2017
• First Submitted That Met QC Criteria: December 1, 2017
• First Posted (ACTUAL): December 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 18, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: MRI; breast cancer; chemotherapy; imaging; peripheral neuropathy; Magnetic Resonance Imaging; Diffusion Tensor Imaging; diffusion; tensor
• Additional Relevant MeSH Terms: Nervous System Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Neuromuscular Diseases; Breast Neoplasms; Peripheral Nervous System Diseases
• Other Study ID Numbers: 1707634514 (OTHER: University of Arizona); P30CA023074 (U.S. NIH Grant/Contract); NCI-2017-01413 (REGISTRY: CTRP (Clinical Trial Reporting Program)); CIPN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No