N/A
N=406
DWI in Assessing Treatment Response in Patients With Breast Cancer Receiving Neoadjuvant Chemotherapy
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01564368 ↗Enrolled (actual)
406
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Pathologic Complete Response (pCR) — 71; 70; 63; 156 Participants — p=0.484
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- diffusion-weighted magnetic resonance imaging (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- American College of Radiology Imaging Network
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pathologic Complete Response (pCR) |
71; 70; 63; 156; 140; 123 | 0.484 |
| SECONDARY Functional Tumor Volume (FTV) as a Predictor of Pathologic Complete Response (pCR) |
71; 70; 63; 156; 140; 123 | <0.001 sig |
| SECONDARY Determine the Accuracy of Predictive Models Including Covariates for Combined Measurement of Change in Tumor ADC Value, Change in Tumor Volume, and Other Variables |
0.71; 0.72; 0.57 | 0.032 sig |
| SECONDARY Repeatability Coefficient (RC)Test-retest Metric for Reproducibility of ADC as Applied to Breast Tumors |
0.16 | — |
| SECONDARY Within-subject Coefficient of Variation (wCV) Test-retest Metric for Reproducibility of ADC as Applied to Breast Tumors |
4.8 | — |
| SECONDARY ICC Test-retest Metric for Reproducibility of ADC as Applied to Breast Tumors |
0.97 | — |
| SECONDARY Agreement Index (AI) Test-retest Metric for Reproducibility of ADC as Applied to Breast Tumors |
0.83 | — |
Summary
RATIONALE: Imaging procedures, such as diffusion-weighted magnetic resonance imaging (DWI) and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI), may help in evaluating how well patients with breast cancer respond to treatment.
PURPOSE: This research trial studies DWI and DCE-MRI in assessing treatment response in patients with breast cancer undergoing neoadjuvant chemotherapy.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Meets I-SPY 2 TRIAL inclusion criteria
- High-risk for recurrent disease
PATIENT CHARACTERISTICS:
- Able to tolerate imaging required by protocol
PRIOR CONCURRENT THERAPY:
- Not specified
Data sourced from ClinicalTrials.gov (NCT01564368). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.