Breast CancerACRIN6702NCT02022579
DCE-MRI and DWI for Detection and Diagnosis of Breast Cancer
A study testing DCE-MRI and DWI in people with Breast Cancer and BIRADS 3, run by American College of Radiology Imaging Network at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, BIRADS 3, BIRADS 4
- What is being tested?
- DCE-MRI and DWI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Breast Cancer, BIRADS 3, BIRADS 4, BIRADS 5
- Being tested
- DCE-MRI and DWI
- Keywords
- Breast Cancer, Diagnosis, Malignant, Benign, Biopsy
- Medical subject headings
- Breast Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCE-MRI and DWIProcedure or surgery
Also called magnetic resonance imaging, MRI, DCE-MRI, DWI
DCE-MRI defined lesion(s) compared with biopsy results or 1-year follow up
| Study group | Role | What they receive |
|---|---|---|
| DCE-MRI and DWI | Experimental | 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. Receives: Procedure: DCE-MRI and DWI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (5)
Optimal ADC Cutoffs by Lesion Type
Whether optimal ADC cutoffs are different for mass and non-mass lesion types;
Measured: 1 year
Local and Central Review Comparison (ADC Value Differences)
Whether site-generated ADC values differ significantly from those obtained by central review;
Measured: 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;
Measured: 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;
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionNov 2018 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American College of Radiology Imaging Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), Eastern Cooperative Oncology Group
- Responsible party
- Sponsor
- Investigators
- Savannah Partridge, PhD, Principal investigator, University of WashingtonHabib Rahbar, MD, Study chair, University of WashingtonThomas Chenevert, PhD, Study chair, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022579
- Sponsor's protocol ID
- ACRIN 6702
- Other IDs
- U01CA080098, U01CA079778
- Acronym
- ACRIN6702
- Status last verified
- Oct 2018
- First submitted
- 16 Dec 2013
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: see ACRIN data sharing policy : https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx
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.
PubMed 33201788
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Study Evaluating the Utility of Diffusion Weighted Imaging for Detection and Diagnosis of Breast Cancer
- ClinicalTrials.gov ID
- NCT02022579
- Acronym / sponsor ID
- ACRIN6702 / ACRIN 6702
- Conditions
- Breast Cancer, BIRADS 3, BIRADS 4, BIRADS 5
- Keywords
- Breast Cancer, Diagnosis, Malignant, Benign, Biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- American College of Radiology Imaging NetworkResearch network
- Collaborators
- National Cancer Institute (NCI), Eastern Cooperative Oncology Group
- Study start
- Jan 2014
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 30 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCE-MRI and DWI | Experimental | Procedure: DCE-MRI and DWISingle 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DCE-MRI and DWIAlso: magnetic resonance imaging, MRI, DCE-MRI, DWIDCE-MRI defined lesion(s) compared with biopsy results or 1-year follow up | Procedure or surgery | DCE-MRI and DWI |
Primary outcome
Apparent Diffusion Coefficient (ADC)
Time frame: 1 year
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.
5 secondary outcomes
Optimal ADC Cutoffs by Lesion Type
Time frame: 1 year
Local and Central Review Comparison (ADC Value Differences)
Time frame: 1 year
Minimum B-Value for Differentiating Lesions
Time frame: 1 year
ADC Measurements/Ratios to Define Subject Lesion Variations
Time frame: 1 year
Combination Variables (ADC Nonzero Minimum B-Value and/or Normalized ADC)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Derived from this study: PubMed 33201788McDonald 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.
- Individual participant dataSharing planned: Yes. see ACRIN data sharing policy : https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Savannah Partridge, PhD principal investigator
University of Washington
Habib Rahbar, MD study chair
University of Washington
Thomas Chenevert, PhD study chair
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DCE-MRI and DWI in people with Breast Cancer and BIRADS 3, run by American College of Radiology Imaging Network at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apparent Diffusion Coefficient (ADC) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02022579, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.