MRI in Assessing Tumor Size in Women With Ductal Carcinoma In Situ
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.
Procedure: magnetic resonance imaging
Procedure: ultrasound imaging
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Ductal Carcinoma in Situ: Protocol Evaluating the Assessment of Extension of Disease by MRI|
- Correlation of tumor extension by MRI with surgical histology [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Study Completion Date:||December 2013|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
|Experimental: MRI||Procedure: magnetic resonance imaging Procedure: radiomammography Procedure: ultrasound imaging|
- Assess the contribution of MRI in accurately determining tumor size in women with ductal breast carcinoma in situ (DCIS).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00874458
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|Principal Investigator:||Claire Chapellier||Centre Antoine Lacassagne|