Clinical trial · Interventional
Diffusion Tensor Imaging in Predicting Development of Chemotherapy Induced Peripheral Neuropathy in Patients With Breast Cancer (CIPN)
Evaluating the Role of Diffusion Tensor Imaging in Predicting Development of Chemotherapy Induced Peripheral Neuropathy in Patients With Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Neuropathy | — | UNRESOLVED | — |
| Neuropathy;Peripheral | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diffusion Tensor Imaging | Procedure | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (non-enhanced MRI using MRN and DTI)
- description
- Patients undergo non-enhanced MRI of both lower extremities using MRN and DTI prior to initiation and after completion of standard of care chemotherapy.
- interventionNames
- Procedure: Diffusion Tensor Imaging
- Other: Laboratory Biomarker Analysis
- Procedure: Magnetic Resonance Imaging
- Other: Questionnaire Administration
Primary outcomes (2)
- 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)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available