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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 : May 17, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

Brief Summary:

This is a single institution, prospective observational clinical trial for women with mammographically detected suspicious calcifications who have been recommended breast biopsy.

The purpose of this study is to determine whether quantitative, multiparametric breast MRI performed prior to biopsy can biologically characterize a 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 as suspicious on mammography 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 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 2022
Estimated Study Completion Date : April 2032

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group 1
Patient with suspicious calcifications identified on mammogram would complete a research quantitative, multiparametric breast MRI prior to core needle biopsy. Patients diagnosed with pure DCIS on breast biopsy and subsequent surgical resection will receive Oncotype DX DCIS score testing.
Diagnostic Test: Breast MRI
Breast MRI prior to clinical breast biopsy

Other: Laboratory Biomarker Analysis
Oncotype Dx testing will be done on surgical specimen of pure DCIS
Other Name: Oncotype Dx




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)



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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 calcifications identified on mammogram without an associated mass. Study participants will undergo an experimental 3 Tesla breast MRI prior to surgical resection, including both DWI and DCE techniques. 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:

• Women aged 18 or older with suspicious calcifications identified on mammography without an associated mass

Exclusion Criteria:

  • Patients with prior history of breast cancer in the ipsilateral breast
  • Patients with a newly diagnosed breast cancer in either 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

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
Contact: Habib Rahbar 206-606-6777 b-imaging-research@seattlecca.org
Contact: Research Coordinator 206-606-6714

Locations
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Research Coordinator    206-606-6714      
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT03495011     History of Changes
Other Study ID Numbers: 9778
R01CA203883 ( U.S. NIH Grant/Contract )
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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:
Breast Carcinoma In Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Ductal, Lobular, and Medullary
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma
Adenocarcinoma
Skin Diseases