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

Sponsor
University of Arizona (Other)
Overall Status
Completed
CT.gov ID
NCT03365895
Collaborator
National Cancer Institute (NCI) (NIH)
17
Enrollment
1
Location
1
Arm
37.7
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Diffusion Tensor Imaging
  • Other: Laboratory Biomarker Analysis
  • Procedure: Magnetic Resonance Imaging
  • Other: Questionnaire Administration
 N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. 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:

  1. Establish normal and abnormal FA and ADC values of the lower extremity nerves.

  2. 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.

  3. 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 Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluating the Role of Diffusion Tensor Imaging in Predicting Development of Chemotherapy Induced Peripheral Neuropathy in Patients With Breast Cancer
Actual Study Start Date :
Aug 11, 2017
Actual Primary Completion Date :
Sep 30, 2019
Actual Study Completion Date :
Oct 2, 2020

Arms and Interventions

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.

Procedure: Diffusion Tensor Imaging
Undergo non-enhanced MRI using MRN and DTI
Other Names:
  • DIFFUSION TENSOR MRI
  • DT-MRI
  • DTI

    • Other: Laboratory Biomarker Analysis
    Correlative studies

    Procedure: Magnetic Resonance Imaging
    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

    • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Changes in quantitative fractional anisotropy (FA) of the lower extremity nerves 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)]

      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) [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 Outcome Measures

    1. 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 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) [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Arizona Cancer Center Tucson Arizona United States 85724

    Sponsors and Collaborators

    • University of Arizona
    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Arizona
    ClinicalTrials.gov Identifier:
    NCT03365895
    Other Study ID Numbers:
    • 1707634514
    • NCI-2017-01413
    • CIPN
    • 1707634514
    • P30CA023074
    First Posted:
    Dec 7, 2017
    Last Update Posted:
    Nov 19, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Arizona
    diffusion
    tensor
    imaging
    chemotherapy
    peripheral neuropathy
    breast cancer
    MRI
    Magnetic Resonance Imaging
    Diffusion Tensor Imaging
    Additional relevant MeSH terms:
    Breast Neoplasms
    Peripheral Nervous System Diseases

    Study Results

    No Results Posted as of Nov 19, 2020