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

Centre Antoine Lacassagne

Status: Completed

Conditions: Breast Cancer

Treatments: Procedure: ultrasound imaging; Procedure: magnetic resonance imaging; Procedure: radiomammography

Study type: Interventional

Funder types: Other

Identifiers

NCT00874458

CALACASS-ID-RCB-2006-A00251-50

CALACASS-CCIS

CDR0000633336

CALACASS-2006/25

INCA-RECF0620

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

MRI

Experimental group

Treatment:

Procedure: ultrasound imaging

Procedure: radiomammography

Procedure: magnetic resonance imaging