MRI in Assessing Tumor Size in Women With Ductal Carcinoma In Situ
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
magnetic resonance imaging
radiomammography
ultrasound imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring ductal breast carcinoma in situ
Eligibility 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
Sites / Locations
- Centre Antoine Lacassagne
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MRI
Arm Description
Outcomes
Primary Outcome Measures
Correlation of tumor extension by MRI with surgical histology
Secondary Outcome Measures
Full Information
NCT ID
NCT00874458
First Posted
April 1, 2009
Last Updated
November 20, 2014
Sponsor
Centre Antoine Lacassagne
1. Study Identification
Unique Protocol Identification Number
NCT00874458
Brief Title
MRI in Assessing Tumor Size in Women With Ductal Carcinoma In Situ
Official Title
Ductal Carcinoma in Situ: Protocol Evaluating the Assessment of Extension of Disease by MRI
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Antoine Lacassagne
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
ductal breast carcinoma in situ
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRI
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance imaging
Intervention Type
Procedure
Intervention Name(s)
radiomammography
Intervention Type
Procedure
Intervention Name(s)
ultrasound imaging
Primary Outcome Measure Information:
Title
Correlation of tumor extension by MRI with surgical histology
Time Frame
up to 1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire Chapellier
Organizational Affiliation
Centre Antoine Lacassagne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
12. IPD Sharing Statement
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MRI in Assessing Tumor Size in Women With Ductal Carcinoma In Situ
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