Breast Cancer Clinical Trial
Diffusion Tensor Imaging in Predicting Development of Chemotherapy Induced Peripheral Neuropathy in Patients With Breast Cancer (CIPN)
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.
Full 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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Tucson Arizona, 85724, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.