DCE-MRI and DWI for Detection and Diagnosis of Breast Cancer (ACRIN6702)

A Multi-Center Study Evaluating the Utility of Diffusion Weighted Imaging for Detection and Diagnosis of Breast Cancer

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

Study Overview

• Status: Unknown
• Conditions: Breast Cancer; BIRADS 3; BIRADS 4; BIRADS 5
• Intervention / Treatment: Procedure: DCE-MRI and DWI

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).

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DCE-MRI and DWI; Single arm study, diagnosis defined as BIRADS 3, 4, or 5 lesion(s) based on DCE-MRI only with DWI collected in tandem as standard practice.	Procedure: DCE-MRI and DWI; DCE-MRI defined lesion(s) compared with biopsy results or 1-year follow up; Other Names: MRI; DCE-MRI; magnetic resonance imaging; DWI; DW-MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apparent Diffusion Coefficient (ADC)	Whether the Apparent Diffusion Coefficient (ADC), when used systematically in conjunction with conventional Dynamic Contrast Enhanced-Magnetic Resonance Imaging (DCE-MRI), can reduce the biopsy rate by at least 20% while maintaining sensitivity.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optimal ADC Cutoffs by Lesion Type	Whether optimal ADC cutoffs are different for mass and non-mass lesion types;	1 year
Local and Central Review Comparison (ADC Value Differences)	Whether site-generated ADC values differ significantly from those obtained by central review;	1 year
Minimum B-Value for Differentiating Lesions	Whether the use of a nonzero minimum b-value to reduce perfusion effects in ADC calculation can increase the area under the curve (AUC) for differentiating benign and malignant lesions;	1 year
ADC Measurements/Ratios to Define Subject Lesion Variations	Whether the use of a normalized ADC measure (tumor/normal ratio) to account for inter- and intra-subject variations in water content and other factors can increase the AUC for differentiating benign and malignant lesions;	1 year
Combination Variables (ADC Nonzero Minimum B-Value and/or Normalized ADC)	Whether ADC with nonzero minimum b-value and/or normalized ADC can reduce the biopsy rate while maintaining sensitivity.	1 year

Collaborators and Investigators

• Sponsor: American College of Radiology Imaging Network
• Collaborators: National Cancer Institute (NCI); Eastern Cooperative Oncology Group
• Investigators: Principal Investigator: Savannah Partridge, PhD, University of Washington; Study Chair: Habib Rahbar, MD, University of Washington; Study Chair: Thomas Chenevert, PhD, University of Michigan

Publications and helpful links

General Publications

• 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.

Helpful Links

• For additional information on the ACRIN 6702 trial, visit ACRIN.ORG.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: December 16, 2013
• First Submitted That Met QC Criteria: December 23, 2013
• First Posted (Estimate): December 30, 2013

Study Record Updates

• Last Update Posted (Actual): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Breast Cancer; Biopsy; Diagnosis; Malignant; Benign
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ACRIN 6702; U01CA080098 (U.S. NIH Grant/Contract); U01CA079778 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: see ACRIN data sharing policy : https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No