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NCT Number: NCT03495011

MRI Characterization of Mammographically Detected DCIS

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Breast Cancer, Stage 0 Adenocarcinoma Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breast MRI

Diagnostic Test

Quantitative, multiparametric breast MRI

laboratory biomarker analysis

Other

Only patients with pure DCIS on surgical excision will have advanced pathologic markers and Oncotype Dx DCIS Score testing.

Other names: Oncotype Dx

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

MRI Characterization of Mammographically Detected Calcifications and Ductal Carcinoma in Situ

Important dates

Study start
2018
Primary completion
2023
Study completion
2032
First posted
Apr 11, 2018
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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