Diffusion Tensor Imaging in Predicting Development of Chemotherapy Induced Peripheral Neuropathy in Patients With Breast Cancer (CIPN)
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer, Neurology |
| Therapuetic Areas: | Neurology, Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 7/14/2018 |
| Start Date: | August 11, 2017 |
| End Date: | August 31, 2020 |
| Contact: | Niyuri Fleming |
| Email: | NFleming@uacc.arizona.edu |
| Phone: | 520-694-9079 |
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.
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.
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.
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.
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
We found this trial at
1
site
Tucson, Arizona 85724
Principal Investigator: Lana H. Gimber, MD, MPH
Phone: 520-694-9079
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