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

November 18, 2020 updated by: University of Arizona

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • The University of Arizona Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Questionnaire Administration
Ancillary studies
Procedure: Diffusion Tensor Imaging
Undergo non-enhanced MRI using MRN and DTI
Other Names:
  • DTI
  • DIFFUSION TENSOR MRI
  • DT-MRI
Procedure: Magnetic Resonance Imaging
Undergo non-enhanced MRI using MRN and DTI
Other Names:
  • MRI
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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)
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.
Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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)
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.
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
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.
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
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.
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
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.
Pre-Treatment (0-30 days prior to receiving first chemotherapy) and on last day of chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Arizona

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 11, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 2, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1707634514 (OTHER: University of Arizona)
  • P30CA023074 (U.S. NIH Grant/Contract)
  • NCI-2017-01413 (REGISTRY: CTRP (Clinical Trial Reporting Program))
  • CIPN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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