Clinical trial NCT02022579: DCE-MRI and DWI for Detection and Diagnosis of Breast Cancer
Official title: A Multi-Center Study Evaluating the Utility of Diffusion Weighted Imaging for Detection and Diagnosis of Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
BIRADS 3
BIRADS 4
BIRADS 5
Keywords: Breast Cancer
Diagnosis
Malignant
Benign
Biopsy
Lead sponsor: American College of Radiology Imaging Network
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: Eastern Cooperative Oncology Group
First posted: 2013-12-30
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A type of magnetic resonance imaging called diffusion weighted imaging (DWI) will be tested to define cancerous from non-cancerous lesions in the breast.

Detailed description: For this study, the investigators plan to evaluate DWI scans performed in women with breast lesions identified by conventional breast MRI. The investigators will determine whether an ADC threshold can be defined for distinguishing benign and malignant lesions on DWI, assess the difference in ADC cutoffs for mass and non-mass lesions, and investigate the potential improvement in accuracy using techniques such as nonzero minimum b-value (to remove perfusion effects in the ADC measures) and normalized ADC measures (to account for variations in water content and other factors).

Eligibility criteria: Inclusion Criteria:

* Willing and able to provide written informed consent;
* 18 years of age or older;
* Successful completion of breast MR examination with DWI required by protocol;
* Undiagnosed breast lesion (BI-RADS 3, 4, or 5) identified on MRI. The BI-RADS assessment must refer to a focal finding within the breast (i.e. mass, non-mass, or focus) as opposed to diffuse processes (e.g. background parenchymal enhancement, skin thickening) or lesions outside the subcutaneous breast (e.g. axillary lymph nodes, focal skin lesions, osseous lesions, etc.).

Exclusion Criteria:

* Participants with current or recent history (within 6 months prior to the MRI) of chemotherapy for cancer;
* Neoadjuvant chemotherapy between MRI and confirmation of lesion outcome (study lesions must be biopsied prior to undergoing any chemotherapy);
* Pregnant (if a female is of childbearing potential - defined as a pre-menopausal female capable of becoming pregnant - confirmation of pregnancy status per the site's standard of practice should be done prior to MRI);
* Unwilling or not suitable to undergo MRI or use the contrast agent gadolinium.

Primary outcomes:
measure: Apparent Diffusion Coefficient (ADC)
timeFrame: 1 year
Secondary outcomes:
measure: Optimal ADC Cutoffs by Lesion Type
timeFrame: 1 year
measure: Local and Central Review Comparison (ADC Value Differences)
timeFrame: 1 year
measure: Minimum B-Value for Differentiating Lesions
timeFrame: 1 year
measure: ADC Measurements/Ratios to Define Subject Lesion Variations
timeFrame: 1 year
measure: Combination Variables (ADC Nonzero Minimum B-Value and/or Normalized ADC)
timeFrame: 1 year
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Savannah Partridge, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Habib Rahbar, MD
role: STUDY_CHAIR
affiliation: University of Michigan
name: Thomas Chenevert, PhD
role: STUDY_CHAIR
References:
citation: McDonald ES, Romanoff J, Rahbar H, Kitsch AE, Harvey SM, Whisenant JG, Yankeelov TE, Moy L, DeMartini WB, Dogan BE, Yang WT, Wang LC, Joe BN, Wilmes LJ, Hylton NM, Oh KY, Tudorica LA, Neal CH, Malyarenko DI, Comstock CE, Schnall MD, Chenevert TL, Partridge SC. Mean Apparent Diffusion Coefficient Is a Sufficient Conventional Diffusion-weighted MRI Metric to Improve Breast MRI Diagnostic Performance: Results from the ECOG-ACRIN Cancer Research Group A6702 Diffusion Imaging Trial. Radiology. 2021 Jan;298(1):60-70. doi: 10.1148/radiol.2020202465. Epub 2020 Nov 17.