Status:
COMPLETED
Diffusion Tensor Imaging in Predicting Development of Chemotherapy Induced Peripheral Neuropathy in Patients With Breast Cancer (CIPN)
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Carcinoma
Breast Cancer
Eligibility:
All Genders
21+ years
Phase:
NA
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 ...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 2 2020
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03365895
Start Date
August 11 2017
End Date
October 2 2020
Last Update
November 19 2020
Active Locations (1)
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1
The University of Arizona Cancer Center
Tucson, Arizona, United States, 85724