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

C

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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