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

Primary Purpose

Breast Carcinoma, Breast Cancer, Neuropathy;Peripheral

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diffusion Tensor Imaging
Laboratory Biomarker Analysis
Magnetic Resonance Imaging
Questionnaire Administration
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Carcinoma focused on measuring diffusion, tensor, imaging, chemotherapy, peripheral neuropathy, breast cancer, MRI, Magnetic Resonance Imaging, Diffusion Tensor Imaging

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Arizona Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (non-enhanced MRI using MRN and DTI)

Arm Description

Patients undergo non-enhanced MRI of both lower extremities using MRN and DTI prior to initiation and after completion of standard of care chemotherapy.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
November 16, 2017
Last Updated
November 18, 2020
Sponsor
University of Arizona
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03365895
Brief Title
Diffusion Tensor Imaging in Predicting Development of Chemotherapy Induced Peripheral Neuropathy in Patients With Breast Cancer (CIPN)
Acronym
CIPN
Official Title
Evaluating the Role of Diffusion Tensor Imaging in Predicting Development of Chemotherapy Induced Peripheral Neuropathy in Patients With Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 11, 2017 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
October 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma, Breast Cancer, Neuropathy;Peripheral, Neuropathy
Keywords
diffusion, tensor, imaging, chemotherapy, peripheral neuropathy, breast cancer, MRI, Magnetic Resonance Imaging, Diffusion Tensor Imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (non-enhanced MRI using MRN and DTI)
Arm Type
Experimental
Arm Description
Patients undergo non-enhanced MRI of both lower extremities using MRN and DTI prior to initiation and after completion of standard of care chemotherapy.
Intervention Type
Procedure
Intervention Name(s)
Diffusion Tensor Imaging
Other Intervention Name(s)
DIFFUSION TENSOR MRI, DT-MRI, DTI
Intervention Description
Undergo non-enhanced MRI using MRN and DTI
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Intervention Description
Undergo non-enhanced MRI using MRN and DTI
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Changes in quantitative fractional anisotropy (FA) of the lower extremity nerves by diffusion tensor imaging (DTI)
Description
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.
Time Frame
Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
Title
Changes in apparent diffusion coefficient (ADC) of the lower extremity nerves by diffusion tensor imaging (DTI)
Description
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.
Time Frame
Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
Secondary Outcome Measure Information:
Title
Inter-reader variability and reproducibility in measuring fractional anisotropy (FA) by diffusion tensor imaging (DTI)
Description
Inter-reader agreement in measuring the quantitative DTI measurements will be assessed by percentage agreement.
Time Frame
Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
Title
Inter-reader variability and reproducibility in measuring apparent diffusion coefficient (ADC) by diffusion tensor imaging (DTI)
Description
Inter-reader agreement in measuring the quantitative DTI measurements will be assessed by percentage agreement.
Time Frame
Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
Title
Normal fractional anisotropy (FA) values of lower extremity nerves
Description
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.
Time Frame
Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
Title
Normal apparent diffusion coefficient (ADC) values of lower extremity nerves
Description
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.
Time Frame
Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
Title
Peripheral neuropathy severity questionnaires
Description
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.
Time Frame
Pre-Treatment (0-30 days prior to receiving first chemotherapy) and on last day of chemotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pavani Chalasani, MD, MPH
Organizational Affiliation
The University of Arizona Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lana Gimber, MD, MPH
Organizational Affiliation
The University of Arizona Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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