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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00874458
First Posted: April 2, 2009
Last Update Posted: November 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Antoine Lacassagne
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Ductal Carcinoma in Situ: Protocol Evaluating the Assessment of Extension of Disease by MRI

Resource links provided by NLM:


Further study details as provided by Centre Antoine Lacassagne:

Primary Outcome Measures:
  • Correlation of tumor extension by MRI with surgical histology [ Time Frame: up to 1 year ]

Enrollment: 40
Study Start Date: April 2007
Study Completion Date: December 2013
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MRI Procedure: magnetic resonance imaging Procedure: radiomammography Procedure: ultrasound imaging

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00874458


Locations
France
Centre Antoine Lacassagne
Nice, France, 06189
Sponsors and Collaborators
Centre Antoine Lacassagne
Investigators
Principal Investigator: Claire Chapellier Centre Antoine Lacassagne
  More Information

Responsible Party: Centre Antoine Lacassagne
ClinicalTrials.gov Identifier: NCT00874458     History of Changes
Other Study ID Numbers: CDR0000633336
CALACASS-CCIS
CALACASS-2006/25
CALACASS-ID-RCB-2006-A00251-50
INCA-RECF0620
First Submitted: April 1, 2009
First Posted: April 2, 2009
Last Update Posted: November 21, 2014
Last Verified: July 2009

Keywords provided by Centre Antoine Lacassagne:
ductal breast carcinoma in situ

Additional relevant MeSH terms:
Carcinoma
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Breast Carcinoma In Situ