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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00874458
First received: April 1, 2009
Last updated: May 12, 2011
Last verified: July 2009

April 1, 2009
May 12, 2011
April 2007
May 2011   (final data collection date for primary outcome measure)
Correlation of tumor extension by MRI with surgical histology [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00874458 on ClinicalTrials.gov Archive Site
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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

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.

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.

Interventional
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Masking: Open Label
Primary Purpose: Diagnostic
Breast Cancer
  • Procedure: magnetic resonance imaging
  • Procedure: radiomammography
  • Procedure: ultrasound imaging
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
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May 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00874458
CDR0000633336, CALACASS-CCIS, CALACASS-2006/25, CALACASS-ID-RCB-2006-A00251-50, INCA-RECF0620
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Centre Antoine Lacassagne
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Principal Investigator: Claire Chapellier Centre Antoine Lacassagne
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP