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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: magnetic resonance imaging; Procedure: radiomammography; Procedure: ultrasound imaging

• Registration Number: NCT00874458
• Lead Sponsor: Centre Antoine Lacassagne

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2009-04-01
• Study First Submitted QC: 2009-04-01
• Study First Posted: 2009-04-02
• Status Verified: 2009-07
• Primary Completion: 2011-05
• Study Completion: 2013-12
• Last Update Submitted: 2014-11-20
• Last Update Posted: 2014-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI	ultrasound imaging	-
MRI	magnetic resonance imaging	-
MRI	radiomammography	-

Primary Outcome Measures

Name	Time	Method
Correlation of tumor extension by MRI with surgical histology	up to 1 year

Trial Locations

Locations (1)

Centre Antoine Lacassagne; 🇫🇷 Nice, France