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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 15, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

Tracking Information
First Submitted Date April 4, 2018
First Posted Date April 11, 2018
Last Update Posted Date May 15, 2019
Actual Study Start Date April 20, 2018
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 4, 2018)
  • 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)
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03495011 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 4, 2018)
  • 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
  • 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
  • Oncotype DCIS Score [ Time Frame: 3.5 years ]
    Develop a multivariate MRI model to identify low risk DCIS (Oncotype DX DCIS score<39)
  • Transfer constant (Ktrans) [ Time Frame: 3.5 years ]
    Assess whether high Ktrans in the peri-tumoral tissue correlates with stromal inflammation (TNFalpha)
  • Fractional perfusion (f) [ Time Frame: 3.5 years ]
    Assess whether high f in the peri-tumoral tissue correlates with angiogenesis (VEGF)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title MRI Characterization of Mammographically Detected DCIS
Official Title MRI Characterization of Mammographically Detected Calcifications and Ductal Carcinoma in Situ
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.

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition Breast Cancer, Stage 0
Intervention
  • 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
Study Groups/Cohorts 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.
Interventions:
  • Diagnostic Test: Breast MRI
  • Other: Laboratory Biomarker Analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 4, 2018)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2032
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Habib Rahbar 206-606-6777 b-imaging-research@seattlecca.org
Contact: Research Coordinator 206-606-6714
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03495011
Other Study ID Numbers 9778
R01CA203883 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Washington
Study Sponsor University of Washington
Collaborators National Cancer Institute (NCI)
Investigators Not Provided
PRS Account University of Washington
Verification Date May 2019