Breast CarcinomaCIPNNCT03365895
Diffusion Tensor Imaging in Predicting Development of Chemotherapy Induced Peripheral Neuropathy in Patients With Breast Cancer (CIPN)
A study testing Diffusion Tensor Imaging, Laboratory Biomarker Analysis and Magnetic Resonance Imaging in people with Breast Carcinoma and Breast Cancer, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Breast Carcinoma, Breast Cancer, Neuropathy;Peripheral
- What is being tested?
- Diffusion Tensor Imaging, Laboratory Biomarker Analysis and Magnetic Resonance Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2017to 2 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Arizona Cancer Center
Tucson, Arizona, 85724
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Breast Carcinoma, Breast Cancer, Neuropathy;Peripheral, Neuropathy
- Being tested
- Diffusion Tensor Imaging, Laboratory Biomarker Analysis, Magnetic Resonance Imaging, Questionnaire Administration
- Keywords
- diffusion, tensor, imaging, chemotherapy, peripheral neuropathy, breast cancer, MRI, Magnetic Resonance Imaging, Diffusion Tensor Imaging
- Medical subject headings
- Breast Neoplasms, Neuritis, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion Tensor ImagingProcedure or surgery
Also called DIFFUSION TENSOR MRI, DT-MRI, DTI
Undergo non-enhanced MRI using MRN and DTI
Laboratory Biomarker AnalysisOther
Correlative studies
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan
Undergo non-enhanced MRI using MRN and DTI
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (non-enhanced MRI using MRN and DTI) | Experimental | Patients undergo non-enhanced MRI of both lower extremities using MRN and DTI prior to initiation and after completion of standard of care chemotherapy. Receives: Procedure: Diffusion Tensor Imaging; Other: Laboratory Biomarker Analysis; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in quantitative fractional anisotropy (FA) of the lower extremity nerves by diffusion tensor imaging (DTI)
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.
Measured: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
Changes in apparent diffusion coefficient (ADC) of the lower extremity nerves by diffusion tensor imaging (DTI)
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.
Measured: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
Secondary outcomes (5)
Inter-reader variability and reproducibility in measuring fractional anisotropy (FA) by diffusion tensor imaging (DTI)
Inter-reader agreement in measuring the quantitative DTI measurements will be assessed by percentage agreement.
Measured: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
Inter-reader variability and reproducibility in measuring apparent diffusion coefficient (ADC) by diffusion tensor imaging (DTI)
Inter-reader agreement in measuring the quantitative DTI measurements will be assessed by percentage agreement.
Measured: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
Normal fractional anisotropy (FA) values of lower extremity nerves
The normal FA and ADC values of the lower extremity nerves will be estimated using mean FA and ADC values with 95% CIs for before and after chemotherapy will be calculated.
Measured: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
Normal apparent diffusion coefficient (ADC) values of lower extremity nerves
The normal FA and ADC values of the lower extremity nerves will be estimated using mean FA and ADC values with 95% CIs for before and after chemotherapy will be calculated.
Measured: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
Peripheral neuropathy severity questionnaires
The correlation between FA and ADC values with the self-reported Patient Neurotoxicity Questionnaire and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-neurotoxicity questionnaire will be evaluated using Pearson or spearman correlation coefficient.
Measured: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and on last day of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start11 Aug 2017
- Primary completion30 Sep 2019
- Study completion2 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Pavani Chalasani, MD, MPH, Principal investigator, The University of Arizona Cancer CenterLana Gimber, MD, MPH, Principal investigator, The University of Arizona Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365895
- Sponsor's protocol ID
- 1707634514
- Other IDs
- NCI-2017-01413, CIPN, 1707634514, P30CA023074
- Acronym
- CIPN
- Status last verified
- Nov 2020
- First submitted
- 16 Nov 2017
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Role of Diffusion Tensor Imaging in Predicting Development of Chemotherapy Induced Peripheral Neuropathy in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT03365895
- Acronym / sponsor ID
- CIPN / 1707634514
- Conditions
- Breast Carcinoma, Breast Cancer, Neuropathy;Peripheral, Neuropathy
- Keywords
- diffusion, tensor, imaging, chemotherapy, peripheral neuropathy, breast cancer, MRI, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Aug 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 2 Oct 2020 (actual)
- First posted
- 7 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (non-enhanced MRI using MRN and DTI) | Experimental | Procedure: Diffusion Tensor Imaging, Other: Laboratory Biomarker Analysis, Procedure: Magnetic Resonance Imaging, Other: Questionnaire AdministrationPatients undergo non-enhanced MRI of both lower extremities using MRN and DTI prior to initiation and after completion of standard of care chemotherapy. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diffusion Tensor ImagingAlso: DIFFUSION TENSOR MRI, DT-MRI, DTIUndergo non-enhanced MRI using MRN and DTI | Procedure or surgery | Diagnostic (non-enhanced MRI using MRN and DTI) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Diagnostic (non-enhanced MRI using MRN and DTI) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI ScanUndergo non-enhanced MRI using MRN and DTI | Procedure or surgery | Diagnostic (non-enhanced MRI using MRN and DTI) |
| Questionnaire AdministrationAncillary studies | Other | Diagnostic (non-enhanced MRI using MRN and DTI) |
Primary outcome
Changes in quantitative fractional anisotropy (FA) of the lower extremity nerves by diffusion tensor imaging (DTI)
Time frame: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
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.
Changes in apparent diffusion coefficient (ADC) of the lower extremity nerves by diffusion tensor imaging (DTI)
Time frame: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
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.
5 secondary outcomes
Inter-reader variability and reproducibility in measuring fractional anisotropy (FA) by diffusion tensor imaging (DTI)
Time frame: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
Inter-reader variability and reproducibility in measuring apparent diffusion coefficient (ADC) by diffusion tensor imaging (DTI)
Time frame: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
Normal fractional anisotropy (FA) values of lower extremity nerves
Time frame: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
Normal apparent diffusion coefficient (ADC) values of lower extremity nerves
Time frame: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
Peripheral neuropathy severity questionnaires
Time frame: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and on last day of chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pavani Chalasani, MD, MPH principal investigator
The University of Arizona Cancer Center
Lana Gimber, MD, MPH principal investigator
The University of Arizona Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diffusion Tensor Imaging, Laboratory Biomarker Analysis and Magnetic Resonance Imaging in people with Breast Carcinoma and Breast Cancer, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in quantitative fractional anisotropy (FA) of the lower extremity nerves by diffusion tensor imaging (DTI) (time frame: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2020.