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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00874458
• Other study ID #: CDR0000633336
• Secondary ID: CALACASS-CCISCAL
• Status: Completed
• Phase: N/A
• First received: April 1, 2009
• Last updated: November 20, 2014
• Start date: April 2007
• Est. completion date: December 2013

Study information

• Verified date: July 2009
• Source: Centre Antoine Lacassagne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating

Intervention

Procedure:
• magnetic resonance imaging

• radiomammography

• ultrasound imaging

Locations

Country	Name	City	State
France	Centre Antoine Lacassagne	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Antoine Lacassagne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of tumor extension by MRI with surgical histology		up to 1 year	No