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NCT Number: NCT03365895

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

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.

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Key information

Conditions

Breast Carcinoma Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neuritis Neuromuscular Diseases Neuropathy Neuropathy;Peripheral Peripheral Nervous System Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

diffusion tensor imaging

Procedure

Undergo non-enhanced MRI using MRN and DTI

Other names: DIFFUSION TENSOR MRI, DT-MRI, DTI

laboratory biomarker analysis

Other

Correlative studies

Magnetic Resonance Imaging

Procedure

Undergo non-enhanced MRI using MRN and DTI

Other names: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Changes in quantitative fractional anisotropy (FA) of the lower extremity nerves by diffusion tensor imaging (DTI)

    Time frame: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)

    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.

  2. Changes in apparent diffusion coefficient (ADC) of the lower extremity nerves by diffusion tensor imaging (DTI)

    Time frame: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)

    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.

Secondary outcomes

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

    Time frame: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)

    Inter-reader agreement in measuring the quantitative DTI measurements will be assessed by percentage agreement.

  2. Inter-reader variability and reproducibility in measuring apparent diffusion coefficient (ADC) by diffusion tensor imaging (DTI)

    Time frame: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)

    Inter-reader agreement in measuring the quantitative DTI measurements will be assessed by percentage agreement.

  3. Normal fractional anisotropy (FA) values of lower extremity nerves

    Time frame: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)

    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.

  4. Normal apparent diffusion coefficient (ADC) values of lower extremity nerves

    Time frame: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)

    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.

  5. Peripheral neuropathy severity questionnaires

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

    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.

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: CIPN

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Dec 7, 2017
Registry last updated
Nov 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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