Breast Cancer, Stage 0NCT03495011
MRI Characterization of Mammographically Detected DCIS
An observational study of Breast Cancer, Stage 0, run by University of Washington at 1 site in United States.
Trial summary
This is a single institution, prospective observational clinical trial for women with mammographically identified calcifications that may represent ductal carcinoma in situ (DCIS). Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Stage 0
- What is being tested?
- Breast MRI and Laboratory Biomarker Analysis
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2018to Apr 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- Women only
- Adult, Older adult
Study population: Women aged 18 or older with suspicious mammographic caclifications or biopsy-proven DCIS with residual calcifications present on mammogram after biopsy. Study participants will undergo an experimental 3 Tesla breast MRI prior to surgical resection, including both DWI and DCE techniques. Only participants who are diagnosed with pure DCIS on both core needle biopsy and surgical resection will remain on study. Tissue from all DCIS lesions will also be sent for outside multi-gene assay testing (Oncotype DX DCIS score, Genomic Health, Redwood City, CA).
Who may be able to join
- [Cohort A] Women aged 18 or older with suspicious calcifications identified on mammography without an associated mass
- [Cohort B] Women aged 18 or older with recent biopsy-proven DCIS with residual calcifications present on mammogram after biopsy
Who cannot join
- Patients with prior history of breast cancer in the ipsilateral breast
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: MRI Characterization of Mammographically Detected Calcifications and Ductal Carcinoma in Situ
This is a single institution, prospective observational clinical trial for women with mammographically identified calcifications that may represent ductal carcinoma in situ (DCIS).
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.
Read the detailed description
The investigators will assess whether MRI signatures can determine which calcifications identified prior to surgical resection actually harbor DCIS, and whether these imaging features correlate with pathologic markers of proliferation (Ki-67) and inflammation (cox-2) within DCIS lesions.
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
- Breast Cancer, Stage 0
- Being tested
- Breast MRI, Laboratory Biomarker Analysis
- Keywords
- Ductal Carcinoma in Situ, MRI, Oncotype Dx
- Medical subject headings
- Breast Carcinoma In Situ, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast MRIDiagnostic test
Quantitative, multiparametric breast MRI
Laboratory Biomarker AnalysisOther
Also called Oncotype Dx
Only patients with pure DCIS on surgical excision will have advanced pathologic markers and Oncotype Dx DCIS Score testing.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Breast MRI; Other: Laboratory Biomarker Analysis | |
| 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. Receives: Diagnostic Test: Breast MRI; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional perfusion (f)
Assess whether high f within DCIS lesions correlates with proliferation (high Ki-67)
Measured: 3.5 years
Tissue diffusion (Dt)
Assess whether low Dt within DCIS lesions correlates with high proliferation (Ki-67)
Measured: 3.5 years
Transfer constant (Ktrans)
Assess whether high Ktrans within DCIS lesions correlates with inflammation (cox-2)
Measured: 3.5 years
Secondary outcomes (5)
Signal enhancement ratio (SER)
Assess whether low SER can exclude the presence of DCIS-associated malignancy at the site of mammographic calcifications
Measured: 3.5 years
Apparent diffusion coefficient (ADC)
Assess whether high ADC can exclude the presence of DCIS-associated malignancy at the site of mammographic calcifications
Measured: 3.5 years
Oncotype DCIS Score
Develop a multivariate MRI model to identify low risk DCIS (Oncotype DX DCIS score<39)
Measured: 3.5 years
Transfer constant (Ktrans)
Assess whether high Ktrans in the peri-tumoral tissue correlates with stromal inflammation (TNFalpha)
Measured: 3.5 years
Fractional perfusion (f)
Assess whether high f in the peri-tumoral tissue correlates with angiogenesis (VEGF)
Measured: 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start20 Apr 2018
- Primary completion30 Apr 2023
- Study completionApr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer, Stage 0Studies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Habib Rahbar, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495011
- Sponsor's protocol ID
- 9778
- Other IDs
- R01CA203883, RG3017004, NCI-2021-12034
- Status last verified
- Jul 2026
- First submitted
- 4 Apr 2018
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Characterization of Mammographically Detected Calcifications and Ductal Carcinoma in Situ
- ClinicalTrials.gov ID
- NCT03495011
- Acronym / sponsor ID
- 9778
- Conditions
- Breast Cancer, Stage 0
- Keywords
- Ductal Carcinoma in Situ, MRI, Oncotype Dx
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- Apr 2032 (estimated)
- First posted
- 11 Apr 2018 (actual)
- 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.
This is a single institution, prospective observational clinical trial for women with mammographically identified calcifications that may represent ductal carcinoma in situ (DCIS).
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.
Detailed description
The investigators will assess whether MRI signatures can determine which calcifications identified prior to surgical resection actually harbor DCIS, and whether these imaging features correlate with pathologic markers of proliferation (Ki-67) and inflammation (cox-2) within DCIS lesions.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Diagnostic Test: Breast MRI, Other: Laboratory Biomarker AnalysisPatient 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. |
| Cohort B | – | Diagnostic Test: Breast MRI, Other: Laboratory Biomarker AnalysisPatient 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women aged 18 or older with suspicious mammographic caclifications or biopsy-proven DCIS with residual calcifications present on mammogram after biopsy. Study participants will undergo an experimental 3 Tesla breast MRI prior to surgical resection, including both DWI and DCE techniques. Only participants who are diagnosed with pure DCIS on both core needle biopsy and surgical resection will remain on study. Tissue from all DCIS lesions will also be sent for outside multi-gene assay testing (Oncotype DX DCIS score, Genomic Health, Redwood City, CA).
Key inclusion criteria (2 listed)
- [Cohort A] Women aged 18 or older with suspicious calcifications identified on mammography without an associated mass
- [Cohort B] Women aged 18 or older with recent biopsy-proven DCIS with residual calcifications present on mammogram after biopsy
Key exclusion criteria (5 listed)
- Patients with prior history of breast cancer in the ipsilateral breast
- 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
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 |
|---|---|---|
| Breast MRIQuantitative, multiparametric breast MRI | Diagnostic test | Cohort A, Cohort B |
| Laboratory Biomarker AnalysisAlso: Oncotype DxOnly patients with pure DCIS on surgical excision will have advanced pathologic markers and Oncotype Dx DCIS Score testing. | Other | Cohort A, Cohort B |
Primary outcome
Fractional perfusion (f)
Time frame: 3.5 years
Assess whether high f within DCIS lesions correlates with proliferation (high Ki-67)
Tissue diffusion (Dt)
Time frame: 3.5 years
Assess whether low Dt within DCIS lesions correlates with high proliferation (Ki-67)
Transfer constant (Ktrans)
Time frame: 3.5 years
Assess whether high Ktrans within DCIS lesions correlates with inflammation (cox-2)
5 secondary outcomes
Signal enhancement ratio (SER)
Time frame: 3.5 years
Apparent diffusion coefficient (ADC)
Time frame: 3.5 years
Oncotype DCIS Score
Time frame: 3.5 years
Transfer constant (Ktrans)
Time frame: 3.5 years
Fractional perfusion (f)
Time frame: 3.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Habib Rahbar principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, Stage 0, run by University of Washington 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 2 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Fractional perfusion (f) (time frame: 3.5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2026.