Diffusion-Weighted Magnetic Resonance Imaging in Assessing Treatment Response in Patients With Breast Cancer Receiving Neoadjuvant Chemotherapy
This study is not yet open for participant recruitment.
Verified September 2012 by National Cancer Institute (NCI)
Sponsor:
American College of Radiology Imaging Network
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01564368
First received: March 24, 2012
Last updated: September 5, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: paclitaxel Other: imaging biomarker analysis Procedure: breast imaging study Procedure: diffusion-weighted magnetic resonance imaging Procedure: dynamic contrast-enhanced magnetic resonance imaging Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Diagnostic |
| Official Title: | Diffusion Weighted MR Imaging Biomarkers for Assessment of Breast Cancer Response to Neoadjuvant Treatment: A Sub-study of the I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And MoLecular Analysis) |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Pathologic complete response (pCR) [ Designated as safety issue: No ]
- Change in ADC value as measured by area under the receiver operating characteristic curve from each treatment timepoint to baseline [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Changes in ADC value, DCE-MRI tumor volume, and SER [ Designated as safety issue: No ]
- Effectiveness of the individual measurement's changes in ADC value, DCE-MRI tumor volume, and SER [ Designated as safety issue: No ]
- Test-retest reproducibility of DW-MRI ADC metric [ Designated as safety issue: No ]
| Estimated Enrollment: | 304 |
| Study Start Date: | August 2012 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- To determine if the change in tumor apparent diffusion coefficient (ADC) value measured from each treatment timepoint to baseline is predictive of pathologic complete response (pCR).
Secondary
- To determine if the combined measurement of change in tumor ADC value, change in tumor volume, and change in peak signal-enhancement ratio (SER) is predictive of pCR.
- To investigate the relative effectiveness of the individual measurements, change in tumor ADC value, change in tumor volume, and change in peak SER for predicting pCR in experimental treatment arms.
- To assess the test-retest reproducibility of ADC metrics applied to breast tumors.
OUTLINE: This is a multicenter study.
Patients undergo diffusion-weighted magnetic resonance imaging (DWI) at baseline, after week 3 of neoadjuvant paclitaxel regimen, and prior to and after completion of 4 courses of neoadjuvant chemotherapy. Patients then undergo surgery. Patients undergo DWI prior to contrast administration for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).
After completion of treatment procedure, patients are followed up for 5 years on the I-SPY 2 TRIAL.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Mitchell Schnall, American College of Radiology Imaging Network |
| ClinicalTrials.gov Identifier: | NCT01564368 History of Changes |
| Other Study ID Numbers: | CDR0000729174, ACRIN-6698 |
| Study First Received: | March 24, 2012 |
| Last Updated: | September 5, 2012 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
stage IV breast cancer HER2-negative breast cancer HER2-positive breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Cyclophosphamide Doxorubicin Paclitaxel Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 22, 2013