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

Centre Antoine Lacassagne

Status: Completed

Conditions: Breast Cancer

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

---

40 participants in 1 patient group

MRI

Experimental group

Treatment:

Procedure: radiomammography

Procedure: ultrasound imaging

Procedure: magnetic resonance imaging