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

This study is currently recruiting participants.
Verified December 2017 by University of Arizona
Sponsor:
ClinicalTrials.gov Identifier:
NCT03365895
First Posted: December 7, 2017
Last Update Posted: December 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Arizona
  Purpose
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 Intervention
Breast Carcinoma Breast Cancer Neuropathy;Peripheral Neuropathy Procedure: Diffusion Tensor Imaging Other: Laboratory Biomarker Analysis Procedure: Magnetic Resonance Imaging Other: Questionnaire Administration

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • 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.

  • 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 Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Estimated Enrollment: 20
Actual Study Start Date: August 11, 2017
Estimated Study Completion Date: August 31, 2020
Estimated Primary Completion Date: September 30, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365895


Contacts
Contact: Niyuri Fleming 520-694-9079 NFleming@uacc.arizona.edu

Locations
United States, Arizona
The University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85724
Contact: Niyuri Fleming    520-694-9079    NFleming@uacc.arizona.edu   
Principal Investigator: Lana H. Gimber, MD, MPH         
Principal Investigator: Pavani Chalasani, MD, MPH         
Sub-Investigator: Kathryn L. Clarke, NP         
Sub-Investigator: Sima Ehsani, MD         
Sub-Investigator: Simran Sindhu, DO         
Sub-Investigator: Lea MacKinnon, MD         
Sponsors and Collaborators
University of Arizona
National Cancer Institute (NCI)
Investigators
Principal Investigator: Lana H. Gimber, MD, MPH The University of Arizona Cancer Center
Principal Investigator: Pavani Chalasani, MD, MPH The University of Arizona Cancer Center
  More Information

Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT03365895     History of Changes
Other Study ID Numbers: 1707634514
NCI-2017-01413 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CIPN
1707634514 ( Other Identifier: The University of Arizona Medical Center-University Campus )
P30CA023074 ( U.S. NIH Grant/Contract )
First Submitted: November 16, 2017
First Posted: December 7, 2017
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neuromuscular Diseases
Nervous System Diseases