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

NCT03365895 | Completed DMC

• 4 other identifiers: 1707634514NCI-2017-01413CIPNP30CA023074
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Carcinoma; Breast Cancer; Neuropathy;Peripheral; Neuropathy

Keywords

diffusion; tensor; imaging; chemotherapy; peripheral neuropathy; breast cancer; MRI; Magnetic Resonance Imaging; Diffusion Tensor Imaging

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Inter-reader variability and reproducibility in measuring fractional anisotropy (FA) by diffusion tensor imaging (DTI)

  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)

  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

  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

  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

  Pre-Treatment (0-30 days prior to receiving first chemotherapy) and on last day of chemotherapy

Study Arms (1)

Diagnostic (non-enhanced MRI using MRN and DTI)

EXPERIMENTAL

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

Interventions

Diffusion Tensor Imaging PROCEDURE

Undergo non-enhanced MRI using MRN and DTI

Also known as: DIFFUSION TENSOR MRI, DT-MRI, DTI

Diagnostic (non-enhanced MRI using MRN and DTI)

Laboratory Biomarker Analysis OTHER

Correlative studies

Diagnostic (non-enhanced MRI using MRN and DTI)

Magnetic Resonance Imaging PROCEDURE

Undergo non-enhanced MRI using MRN and DTI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Diagnostic (non-enhanced MRI using MRN and DTI)

Questionnaire Administration OTHER

Ancillary studies

Diagnostic (non-enhanced MRI using MRN and DTI)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

The University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neuritis; Peripheral Nervous System Diseases

Interventions

Diffusion Tensor Imaging; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Pavani Chalasani, MD, MPH

  The University of Arizona Cancer Center

  PRINCIPAL INVESTIGATOR

• Lana Gimber, MD, MPH

  The University of Arizona Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: December 7, 2017
• Study Start: August 11, 2017
• Primary Completion: September 30, 2019
• Study Completion: October 2, 2020
• Last Updated: November 19, 2020

Record last verified: 2020-11

Locations

US (1)