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


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Correlation of tumor extension by MRI with surgical histology

Safety Issue:

No

Principal Investigator

Claire Chapellier

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Antoine Lacassagne

Authority:

United States: Federal Government

Study ID:

CDR0000633336

NCT ID:

NCT00874458

Start Date:

April 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • ductal breast carcinoma in situ
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating
  • Carcinoma, Ductal, Breast
  • Carcinoma, Ductal

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