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MRI Characterization of Mammographically Detected DCIS

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ClinicalTrials.gov Identifier: NCT03495011
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : February 9, 2023
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Washington

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Breast Cancer, Stage 0 Diagnostic Test: Breast MRI Other: Laboratory Biomarker Analysis

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
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MRI Characterization of Mammographically Detected Calcifications and Ductal Carcinoma in Situ
Actual Study Start Date : April 20, 2018
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2032

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Diagnostic Test: Breast MRI
Quantitative, multiparametric breast MRI

Other: Laboratory Biomarker Analysis
Only patients with pure DCIS on surgical excision will have advanced pathologic markers and Oncotype Dx DCIS Score testing.
Other Name: Oncotype Dx
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.
 Diagnostic Test: Breast MRI
Quantitative, multiparametric breast MRI

Other: Laboratory Biomarker Analysis
Only patients with pure DCIS on surgical excision will have advanced pathologic markers and Oncotype Dx DCIS Score testing.
Other Name: Oncotype Dx


Outcome Measures
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Primary Outcome Measures :
  1. Fractional perfusion (f) [ Time Frame: 3.5 years ]
    Assess whether high f within DCIS lesions correlates with proliferation (high Ki-67)

  2. Tissue diffusion (Dt) [ Time Frame: 3.5 years ]
    Assess whether low Dt within DCIS lesions correlates with high proliferation (Ki-67)

  3. Transfer constant (Ktrans) [ Time Frame: 3.5 years ]
    Assess whether high Ktrans within DCIS lesions correlates with inflammation (cox-2)


Secondary Outcome Measures :
  1. Signal enhancement ratio (SER) [ Time Frame: 3.5 years ]
    Assess whether low SER can exclude the presence of DCIS-associated malignancy at the site of mammographic calcifications

  2. Apparent diffusion coefficient (ADC) [ Time Frame: 3.5 years ]
    Assess whether high ADC can exclude the presence of DCIS-associated malignancy at the site of mammographic calcifications

  3. Oncotype DCIS Score [ Time Frame: 3.5 years ]
    Develop a multivariate MRI model to identify low risk DCIS (Oncotype DX DCIS score<39)

  4. Transfer constant (Ktrans) [ Time Frame: 3.5 years ]
    Assess whether high Ktrans in the peri-tumoral tissue correlates with stromal inflammation (TNFalpha)

  5. Fractional perfusion (f) [ Time Frame: 3.5 years ]
    Assess whether high f in the peri-tumoral tissue correlates with angiogenesis (VEGF)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
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).
Criteria

Inclusion Criteria:

  • [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

Exclusion Criteria for Both Cohorts:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495011


Contacts
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Contact: Habib Rahbar 206-606-6777 b-imaging-research@seattlecca.org
Contact: Mary Lynn Bryant 937-540-0802 b-imaging-research@seattlecca.org

Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Research Coordinator    206-606-6714    b-imaging-research@seattlecca.org   
Principal Investigator: Habib Rahbar         
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Habib Rahbar Fred Hutch/University of Washington Cancer Consortium
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT03495011    
Other Study ID Numbers: 9778
R01CA203883 ( U.S. NIH Grant/Contract )
RG3017004 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
NCI-2021-12034 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: February 9, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Washington:
Ductal Carcinoma in Situ
MRI
Oncotype Dx
Additional relevant MeSH terms:
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Carcinoma in Situ
Breast Carcinoma In Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases