An interventional study of Diffusion Tensor Imaging and Laboratory Biomarker Analysis in Breast Carcinoma, Breast Cancer and Neuropathy;Peripheral, sponsored by University of Arizona. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2020-11-19.
Sponsored by University of Arizona · Not applicable, Interventional, and Diagnostic
Among 32 studies in Breast Neoplasms by University of Arizona — 3 open to participants now, 4 under way, none of them phase 3. Breast Neoplasms · University of Arizona.
Among the 32 studies in Breast Neoplasms by University of Arizona, this one is the 18th largest by enrollment of the 28 interventional ones that give a count, is the only one that started in 2017, is one of 10 with no phase, and was the 18th registered.
14,829 studies on the registry are indexed under Breast Neoplasms; 3,318 are open to participants now.
Browse Breast Neoplasms studies →3 of the 32 studies in Breast Neoplasms by University of Arizona are open now, in 1 country. Recruiting first, the newest first:
University of Arizona · Sites in United States
Ages 40+ · Women only · Healthy volunteers
University of Arizona · Sites in United States
Ages 18+ · Healthy volunteers
University of Arizona
Ages 40+ · Women only · Healthy volunteers
By country, each count listing its studies:
Of the 2,398 Breast Neoplasms studies recruiting now, 1,569 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 21 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
32 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 17 is below the median of 72 across 10,900 interventional studies indexed under Breast Neoplasms.
Median enrollment 28 across the 28 interventional studies, 83 across the 4 observational. Of the 25 that completed or were terminated, 10 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
University of Arizona is the lead sponsor of 477 studies on the registry; 89 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 30 (59%) have results posted.
3 of the studies in Breast Neoplasms by University of Arizona that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07705100University of ArizonaClinical Feasibility Study of Upright, Low-dose, High-resolution, 3D Breast CT (UBCT). | 2026-12-31 |
| NCT05715255University of ArizonaAdaptive Symptom Self-Management Immunotherapy Study | 2027-04-30 |
| NCT05676255University of ArizonaThe Breast Cancer Survivors and Partners Online Research Together (SUPORT) Project | 2027-06 |
Add all 3 to your calendar (.ics) → With an account.
Among the 32 studies in Breast Neoplasms by University of Arizona, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergo non-enhanced MRI of both lower extremities using MRN and DTI prior to initiation and after completion of standard of care chemotherapy.
Procedure: Diffusion Tensor Imaging · Other: Laboratory Biomarker Analysis · Procedure: Magnetic Resonance Imaging · Other: Questionnaire Administration
Undergo non-enhanced MRI using MRN and DTI
Also known as: DIFFUSION TENSOR MRI, DT-MRI, DTI
Correlative studies
Undergo non-enhanced MRI using MRN and DTI
Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Ancillary studies
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.
Time frame: 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.
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 fractional anisotropy (FA) by diffusion tensor imaging (DTI)
Inter-reader agreement in measuring the quantitative DTI measurements will be assessed by percentage agreement.
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)
Inter-reader agreement in measuring the quantitative DTI measurements will be assessed by percentage agreement.
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
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.
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
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.
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
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.
Time frame: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and on last day of chemotherapy
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Aug 2017 to primary completion in Sep 2019, 25 months.
Of 2,662 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's 25 months is below that.
Counting every sponsor, half of 2,772 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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