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
  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: Masking: 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 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
Primary Completion Date: May 2011 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

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
Study First Received: April 1, 2009
Last Updated: May 12, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
ductal breast carcinoma in situ

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

ClinicalTrials.gov processed this record on October 21, 2014