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

History of Changes

Tracking Information

First Received Date ^ICMJE

April 1, 2009

Last Updated Date

May 12, 2011

Start Date ^ICMJE

April 2007

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Correlation of tumor extension by MRI with surgical histology [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00874458 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Procedure: magnetic resonance imaging
Procedure: radiomammography
Procedure: ultrasound imaging

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00874458

Other Study ID Numbers ^ICMJE

CDR0000633336, CALACASS-CCIS, CALACASS-2006/25, CALACASS-ID-RCB-2006-A00251-50, INCA-RECF0620

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Centre Antoine Lacassagne

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Claire Chapellier

Centre Antoine Lacassagne

Information Provided By

National Cancer Institute (NCI)

Verification Date

July 2009

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

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