Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
122 participants
OBSERVATIONAL
2018-04-20
2032-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The purpose of this study is to determine whether quantitative, multiparametric breast MRI performed prior to surgical resection can biologically characterize this common pre-invasive malignancy, ductal carcinoma in situ (DCIS), which typically presents in asymptomatic women as suspicious calcifications on mammography.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
MRI in Assessing Tumor Size in Women With Ductal Carcinoma In Situ
NCT00874458
MRI and Gene Expression in Diagnosing Patients With Ductal Breast Cancer In Situ
NCT02352883
Breast MRI as a Preoperative Tool for DCIS
NCT00605982
Contrast-Enhanced MRI for the Characterization of Ductal Carcinoma in Situ (DCIS)
NCT00804128
Magnetic Resonance Imaging of Breast Cancer
NCT01035112
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The investigators will also explore whether quantitative MRI features in the peri-tumoral region correlate with prognostic microenvironment markers of inflammation (TNFα) and angiogenesis (VEGF). Finally, investigators will assess whether a multivariate model using these markers can accurately predict risk of recurrence based on a multi-gene assay (Oncotype DX DCIS score).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort A
Patient with recently identified calcifications on mammography requiring biopsy. Patients will undergo a quantitative, multiparametric breast MRI as part of their clinical care. MRI will not change need for biopsy, but could identify additional suspicious sites. Only patients diagnosed with pure DCIS at biopsy and eventual surgical excision will receive Oncotype DX DCIS score testing.
Breast MRI
Quantitative, multiparametric breast MRI
Laboratory Biomarker Analysis
Only patients with pure DCIS on surgical excision will have advanced pathologic markers and Oncotype Dx DCIS Score testing.
Cohort B
Patient with recent diagnosis of biopsy-proven DCIS would complete a research quantitative, multiparametric breast MRI as part of their clinical care. Only patients diagnosed with pure DCIS at surgical resection will receive Oncotype DX DCIS score testing.
Breast MRI
Quantitative, multiparametric breast MRI
Laboratory Biomarker Analysis
Only patients with pure DCIS on surgical excision will have advanced pathologic markers and Oncotype Dx DCIS Score testing.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Breast MRI
Quantitative, multiparametric breast MRI
Laboratory Biomarker Analysis
Only patients with pure DCIS on surgical excision will have advanced pathologic markers and Oncotype Dx DCIS Score testing.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* \[Cohort B\] Women aged 18 or older with recent biopsy-proven DCIS with residual calcifications present on mammogram after biopsy
Exclusion Criteria
* Patients with a newly diagnosed breast cancer in the contralateral breast
* Contra-indication to contrast-enhanced breast MRI (e.g. renal insufficiency with GFR\<60, contrast allergy, incompatible metal)
* Patients who currently are undergoing chemoprevention therapy (e.g. aromatase inhibitors or selective estrogen receptor modulators)
* Women who are pregnant
18 Years
80 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
National Institutes of Health (NIH)
NIH
University of Washington
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Habib Rahbar
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RG3017004
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2021-12034
Identifier Type: REGISTRY
Identifier Source: secondary_id
9778
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.