DCE-MRI and DWI for Detection and Diagnosis of Breast Cancer

Breast Cancer Clinical Trial

— ACRIN6702  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02022579
• Other study ID #: ACRIN 6702
• Secondary ID: U01CA080098U01CA
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2014
• Est. completion date: March 2019

Study information

• Verified date: October 2018
• Source: American College of Radiology Imaging Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: March 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• BIRADS 3
• BIRADS 4
• BIRADS 5
• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• DCE-MRI and DWI
DCE-MRI defined lesion(s) compared with biopsy results or 1-year follow up

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
American College of Radiology Imaging Network	Eastern Cooperative Oncology Group, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Optimal ADC Cutoffs by Lesion Type	Whether optimal ADC cutoffs are different for mass and non-mass lesion types;	1 year
Secondary	Local and Central Review Comparison (ADC Value Differences)	Whether site-generated ADC values differ significantly from those obtained by central review;	1 year
Secondary	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
Secondary	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
Secondary	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

External Links

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