Magnetic Resonance Imaging to Improve Treatment Methods for Ductal Carcinoma in Situ

Status: closed to accrual

This study investigates if magnetic resonance imaging (MRI) can improve ductal carcinoma in situ (DCIS) treatments. MRI is a medical imaging method that uses magnets to make images of the body. MRI helps doctors to tell the difference between cancer and normal tissue in the body. Imaging methods such as, MRI may help provide additional information that could allow doctors to provide more personalized treatments of DCIS, including less surgery and/or radiation therapy.

Inclusion Criteria

ARM A: Women aged 18 or older with suspicious calcifications identified on mammography without an associated mass
ARM B: Women aged 18 or older with newly diagnosed pure DCIS on core needle biopsy with residual calcifications on mammography

Exclusion Criteria

BOTH ARMS: Patients with prior history of breast cancer in the ipsilateral breast
BOTH ARMS: Contra-indication to contrast-enhanced breast MRI (e.g., renal insufficiency with glomerular filtration rate [GFR] < 60, contrast allergy, incompatible metal)
BOTH ARMS: Patients who currently are undergoing chemoprevention therapy (e.g., aromatase inhibitors or selective estrogen receptor modulators)
BOTH ARMS: Women who are pregnant
ARM A: Patients with a newly diagnosed breast cancer (DCIS or invasive breast cancer) in either breast
ARM B: Patients with newly diagnosed invasive breast cancer in either breast
ARM B: Patients with no residual suspicious calcifications on mammogram or with a hematoma or post-biopsy changes that obscure the residual calcifications
Patients who ultimately elect not to have surgery within 6 months from date of a cancer diagnosis
Patients whose surgical excision specimens cannot be obtained due to being performed at an outside institution

PRIMARY OBJECTIVES:

I. Assess whether low Dt and high f within ductal carcinoma in situ (DCIS) lesions correlate with proliferation (Ki-67).

II. Assess whether high K^ trans within DCIS lesions correlates with inflammation (cox-2).

SECONDARY OBJECTIVES:

I. Assess whether high Ktrans, signal enhancement ratio (SER), and f in peri-tumoral tissue correlate with stromal inflammation (tumor necrosis factor-alpha [TNFa]) and angiogenesis (VEGF).

II. Determine whether low SER and high ADC can exclude the presence of DCIS-associated malignancy at the site of mammographic calcifications.

IIa. Characterize diagnostic performance of each magnetic resonance imaging (MRI) marker and their combination to identify malignancy.

IIb. Determine if there is a diagnostic threshold for the MRI markers that achieves a negative predictive value (NPV) >= 98% and estimate the corresponding percentage of biopsies avoided.

III. Develop a multivariate MRI model to identify low risk (Oncotype DCIS diagnosis [DX] score < 39) DCIS.

IV. Estimate and compare the accuracy of additional quantitative magnetic resonance (MR) biomarkers of DCIS lesions, including mean apparent diffusion coefficient (ADC), normalized ADC, diffusion weighted imaging [DWI] contrast-to-noise ratio [CNR], Kep, and Ve, to discriminate Ki67, cox-2, and Oncotype DCIS score.

V. Estimate and compare the accuracy of basic MR biomarkers (dynamic contrast-enhanced [DCE] maximum lesion size, morphology type, DCE peak initial enhancement, and DCE delayed worst curve kinetics features) to discriminate Ki-67, cox-2, and Oncotype DCIS score.

VI. Estimate the reproducibility of the measured MR parameters (ADC minimum (min), mean ADC, normalized ADC, DWI CNR, maximum DCE lesion size, Ktrans, SER, Kep, and Ve).

OUTLINE: Patients are assigned to 1 of 2 arms.

ARM A: Patients undergo multiparametric breast MRI for over 1 hour. Patients undergo image-guided biopsy to determine if the patient is qualified to undergo surgical resection.

ARM B: Patients undergo multiparametric breast MRI for over 1 hour. Patients also undergo surgical resection.

After completion of the study, patients are followed for up to 10 years.

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Magnetic Resonance Imaging to Improve Treatment Methods for Ductal Carcinoma in Situ

Description

Eligibility Criteria

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Trial Objectives and Outline

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Trial IDs

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