Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00302120
Status:
UNKNOWN
Last Update Posted:
2008-06-10
First Post:
2006-03-10
Brief Title:
The MONET - Study MR Mammography of Nonpalpable Breast Tumors
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
MR Mammography Randomized Controlled Trial to Study Efficiency of MR Mammography in Reducing the Number of Invasive Interventions in Nonpalpable Suspicious Breast Lesions The MONET - Study
Status:
UNKNOWN
Status Verified Date:
2008-06
Last Known Status:
RECRUITING
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:
MONET
Brief Summary:
The purpose of this study is to determine whether performing MRI of the breast will improve breast cancer management by reducing the number of biopsies and in case of malignancy allowing one-stage surgical excision of the tumor
Detailed Description:
Each year 7000 women present with nonpalpable suspicious breast lesions on mammography in the Netherlands In the usual care situation these lesions are detected by mammography and ultrasonography and pathologically characterized by analysis of large core needle biopsy material In case of malignancy these lesions are surgically removed First a wire is placed in the breast with the tip of the wire within 1 cm of the tumor and then the surgeon follows the wire and removes the lesion Unfortunately about 25 of women require more that one surgical procedure to remove all tumorous tissue This is caused by incorrect presurgical diagnosis of the extent and invasiveness of the disease multifocality multicentricity lymph node involvement We hypothesize that MR mammography will improve presurgical diagnosis and differentiation of lesions and thereby decrease the number of invasive surgical procedures primary outcome and number of invasive biopsies secondary outcome
Study Oversight
Has Oversight DMC:
None
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?:
None