Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT00874458
Status:
COMPLETED
Last Update Posted:
2025-09-30
First Post:
2009-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MRI in Assessing Tumor Size in Women With Ductal Carcinoma In Situ
Sponsor:
Centre Antoine Lacassagne
Organization:
Study Overview
Official Title:
Ductal Carcinoma in Situ: Protocol Evaluating the Assessment of Extension of Disease by MRI
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: