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

Ductal Carcinoma in Situ: Protocol Evaluating the Assessment of Extension of Disease by MRI

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00874458

Enrollment

Registered

2009-04-02

Start date

2007-04-30

Completion date

2013-12-31

Last updated

2025-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

ductal breast carcinoma in situ

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREmagnetic resonance imaging

PROCEDUREradiomammography

PROCEDUREultrasound imaging

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 120 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Correlation of tumor extension by MRI with surgical histology	up to 1 year

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026