Contrast-Enhanced MRI for the Characterization of Ductal Carcinoma in Situ (DCIS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-01

Study Completion Date

2024-01-05

Brief Summary

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\*REFERRALS TO THIS TRIAL MUST BE THROUGH BREAST CARE CLINICIANS ONLY\*

RATIONALE: Diagnostic procedures, such as contrast-enhanced MRI, may help find and diagnose ductal carcinoma in situ.

PURPOSE: This study is to develop and refine magnetic resonance (MR) imaging methods for pre-operative staging of ductal carcinoma in situ, a pre-invasive form of breast cancer, and atypical ductal hyperplasia, a risk factor for developing cancer.

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Detailed Description

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OBJECTIVES:

* Compare the DCIS optimized MRI to the standard clinical MRI. Using a scale of 1-5 from poor to excellent, images will be assessed for conspicuity of DCIS and atypical ductal hyperplasia (ADH) lesions, agreement of disease extent with biopsy, and overall image quality (artifact level, uniformity of fat suppression, contrast to noise ratio and signal to noise ratio).
* Subjects with ADH, a benign condition that can also show enhancement on MRI, will be enrolled to explore the utility of the DCIS optimized MRI for distinguishing DCIS and ADH.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Breast Cancer patients

Adult, breast cancer patients with confirmed Ductal Carcinoma in Situ (DCIS) or atypical ductal hyperplasia (ADH)

Magnetic Resonance Imaging (MRI)

Intervention Type PROCEDURE

Undergo MRI

Gadavist

Intervention Type DRUG

Gadavist injection is a paramagnetic macrocyclic contrast agent administered for magnetic resonance imaging

Interventions

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Magnetic Resonance Imaging (MRI)

Undergo MRI

Intervention Type PROCEDURE

Gadavist

Gadavist injection is a paramagnetic macrocyclic contrast agent administered for magnetic resonance imaging

Intervention Type DRUG

Other Intervention Names

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MRI Gadobutrol

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

* Patients at the University of California, San Francisco Breast Care Center meeting the following criteria:

* Biopsy proven ductal carcinoma in situ (DCIS) of the breast.
* Has undergone mammography within the past 60 days.
* ADH patients: over 18, no prior history of breast disease.

PATIENT CHARACTERISTICS:

* Referrals to this trial are through breast care clinicians only
* Not pregnant or nursing (or stopped nursing within the past 3 months)
* Negative pregnancy test
* No contraindication to MRI (e.g., implanted pacemaker, implanted ferromagnetic device, ferromagnetic aneurysm clip, severe claustrophobia, ocular metal fragments, or shrapnel injury)

PRIOR CONCURRENT THERAPY:

* More than 2 years since prior surgery to the ipsilateral breast (patient)
* No prior radiotherapy to the ipsilateral breast (patient)
* No prior cytotoxic regimens (patient)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No