Clinical trial NCT03365895: Diffusion Tensor Imaging in Predicting Development of Chemotherapy Induced Peripheral Neuropathy in Patients With Breast Cancer (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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Carcinoma
Breast Cancer
Neuropathy;Peripheral
Neuropathy
Keywords: diffusion
tensor
imaging
chemotherapy
peripheral neuropathy
breast cancer
MRI
Magnetic Resonance Imaging
Diffusion Tensor Imaging
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-12-07
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Changes in quantitative fractional anisotropy (FA) of the lower extremity nerves by diffusion tensor imaging (DTI)
timeFrame: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
measure: Changes in apparent diffusion coefficient (ADC) of the lower extremity nerves by diffusion tensor imaging (DTI)
timeFrame: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
Secondary outcomes:
measure: Inter-reader variability and reproducibility in measuring fractional anisotropy (FA) by diffusion tensor imaging (DTI)
timeFrame: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
measure: Inter-reader variability and reproducibility in measuring apparent diffusion coefficient (ADC) by diffusion tensor imaging (DTI)
timeFrame: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
measure: Normal fractional anisotropy (FA) values of lower extremity nerves
timeFrame: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
measure: Normal apparent diffusion coefficient (ADC) values of lower extremity nerves
timeFrame: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
measure: Peripheral neuropathy severity questionnaires
timeFrame: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and on last day of chemotherapy
Other outcomes:
Locations:
city: Tucson
country: United States
facility: The University of Arizona Cancer Center
state: Arizona
Study officials:
affiliation: The University of Arizona Cancer Center
name: Pavani Chalasani, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Arizona Cancer Center
name: Lana Gimber, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: