MRI in Assessing Tumor Size in Women With Ductal Carcinoma In Situ - Full Text View

Sponsored by:	Centre Antoine Lacassagne
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00874458

Purpose

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.

Condition	Intervention
Breast Cancer	Procedure: magnetic resonance imaging Procedure: radiomammography Procedure: ultrasound imaging

Study Type:	Interventional
Study Design:	Diagnostic, Open Label
Official Title:	Ductal Carcinoma in Situ: Protocol Evaluating the Assessment of Extension of Disease by MRI

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer MRI Scans

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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

Estimated Enrollment:	40
Study Start Date:	April 2007
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874458

Locations

France
Centre Antoine Lacassagne	Recruiting
Nice, France, 06189
Contact: Claire Chapellier 33-49-203-1000

Sponsors and Collaborators

Centre Antoine Lacassagne

Investigators

Principal Investigator:

Claire Chapellier

Centre Antoine Lacassagne

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000633336, CALACASS-CCIS, CALACASS-2006/25, CALACASS-ID-RCB-2006-A00251-50, INCA-RECF0620
Study First Received:	April 1, 2009
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00874458 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

ductal breast carcinoma in situ

Study placed in the following topic categories:

Carcinoma, Ductal
Skin Diseases
Carcinoma in Situ
Breast Neoplasms
Carcinoma, Ductal, Breast

Carcinoma, Intraductal, Noninfiltrating
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Skin Diseases
Breast Neoplasms
Carcinoma
Carcinoma, Ductal
Neoplasms
Neoplasms by Site

Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Neoplasms, Ductal, Lobular, and Medullary
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 11, 2009