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

Primary Purpose

Breast Cancer, BIRADS 3, BIRADS 4

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

DCE-MRI and DWI

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast Cancer, Diagnosis, Malignant, Benign, Biopsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

University of Washington

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DCE-MRI and DWI

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Optimal ADC Cutoffs by Lesion Type

Whether optimal ADC cutoffs are different for mass and non-mass lesion types;

Local and Central Review Comparison (ADC Value Differences)

Whether site-generated ADC values differ significantly from those obtained by central review;

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;

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;

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.

Full Information

NCT ID

NCT02022579

First Posted

December 16, 2013

Last Updated

October 9, 2018

Sponsor

American College of Radiology Imaging Network

Collaborators

National Cancer Institute (NCI), Eastern Cooperative Oncology Group

1. Study Identification

Unique Protocol Identification Number

NCT02022579

Brief Title

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

Acronym

ACRIN6702

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 2014 (undefined)

Primary Completion Date

November 2018 (Anticipated)

Study Completion Date

March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

American College of Radiology Imaging Network

Collaborators

National Cancer Institute (NCI), Eastern Cooperative Oncology Group

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, BIRADS 3, BIRADS 4, BIRADS 5

Keywords

Breast Cancer, Diagnosis, Malignant, Benign, Biopsy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DCE-MRI and DWI

Arm Type

Experimental

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

DCE-MRI and DWI

Other Intervention Name(s)

magnetic resonance imaging, MRI, DCE-MRI, DWI, DW-MRI

Intervention Description

DCE-MRI defined lesion(s) compared with biopsy results or 1-year follow up

Primary Outcome Measure Information:

Title

Apparent Diffusion Coefficient (ADC)

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Optimal ADC Cutoffs by Lesion Type

Description

Whether optimal ADC cutoffs are different for mass and non-mass lesion types;

Time Frame

1 year

Title

Local and Central Review Comparison (ADC Value Differences)

Description

Whether site-generated ADC values differ significantly from those obtained by central review;

Time Frame

1 year

Title

Minimum B-Value for Differentiating Lesions

Description

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;

Time Frame

1 year

Title

ADC Measurements/Ratios to Define Subject Lesion Variations

Description

Time Frame

1 year

Title

Combination Variables (ADC Nonzero Minimum B-Value and/or Normalized ADC)

Description

Whether ADC with nonzero minimum b-value and/or normalized ADC can reduce the biopsy rate while maintaining sensitivity.

Time Frame

1 year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Savannah Partridge, PhD

Organizational Affiliation

University of Washington

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Habib Rahbar, MD

Organizational Affiliation

University of Washington

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Thomas Chenevert, PhD

Organizational Affiliation

University of Michigan

Official's Role

Study Chair

Facility Information:

Facility Name

University of Washington

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

see ACRIN data sharing policy : https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx

Citations:

PubMed Identifier

33201788

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.

Results Reference

derived

Links:

URL

http://www.acrin.org

Description

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

Learn more about this trial

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

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