MRI in Assessing Tumor Size in Women With Ductal Carcinoma In Situ

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

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2013-12-31

Brief Summary

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RATIONALE: Diagnostic procedures, such as MRI, may help find ductal carcinoma in situ and find out how far the disease has spread.

PURPOSE: This clinical trial is studying how well MRI works in assessing tumor size in women with ductal carcinoma in situ.

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Detailed Description

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OBJECTIVES:

Primary

* Assess the contribution of MRI in accurately determining tumor size in women with ductal breast carcinoma in situ (DCIS).

Secondary

* Evaluate the sensitivity of MRI in detecting DCIS.
* Evaluate the contribution of mammography in accurately determining tumor size.
* Compare the contribution of MRI vs mammography in assessing tumor extension.
* Compare the contribution of MRI vs mammography in assessing dense breasts.
* Evaluate the morphology of DCIS by MRI.
* Evaluate the curve of dynamic MRI in assessing DCIS.
* Evaluate the impact of nuclear grade of DCIS by MRI.
* Evaluate the rate of revision surgery.

OUTLINE: Patients undergo clinical examination, mammography, ultrasound imaging, unilateral breast MRI, and tissue sampling.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MRI

Group Type EXPERIMENTAL

magnetic resonance imaging

Intervention Type PROCEDURE

radiomammography

Intervention Type PROCEDURE

ultrasound imaging

Intervention Type PROCEDURE

Interventions

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magnetic resonance imaging

Intervention Type PROCEDURE

radiomammography

Intervention Type PROCEDURE

ultrasound imaging

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Diagnosis of ductal breast carcinoma in situ

* Any grade disease allowed
* Unifocal disease by mammography
* No history of breast cancer
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* WHO performance status 0-2
* Glomerular filtration rate ≥ 30 mL/min
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No allergy or contraindication to contrast MRI
* No pacemaker or vascular clip

PRIOR CONCURRENT THERAPY:

* No prior or concurrent liver transplantation

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No