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

Breast Cancer Clinical Trial

— CIPN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03365895
• Other study ID #: 1707634514
• Secondary ID: NCI-2017-01413CI
• Status: Completed
• Phase: N/A
• Start date: August 11, 2017
• Est. completion date: October 2, 2020

Study information

• Verified date: November 2020
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 2, 2020
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Carcinoma
• Breast Neoplasms
• Neuropathy
• Neuropathy;Peripheral
• Peripheral Nervous System Diseases

Intervention

Procedure:
• Diffusion Tensor Imaging
Undergo non-enhanced MRI using MRN and DTI

Other:
• Laboratory Biomarker Analysis
Correlative studies

Procedure:
• Magnetic Resonance Imaging
Undergo non-enhanced MRI using MRN and DTI

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	The University of Arizona Cancer Center	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
Primary	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.	Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
Secondary	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.	Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
Secondary	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.	Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
Secondary	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.	Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
Secondary	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.	Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
Secondary	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.	Pre-Treatment (0-30 days prior to receiving first chemotherapy) and on last day of chemotherapy