Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003302
Status:
COMPLETED
Last Update Posted:
2019-09-25
First Post:
1999-11-01
Brief Title:
MRI to Detect Breast Tumors in Women
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Abramson Cancer Center at Penn Medicine
Study Overview
Official Title:
Breast MRI Protocol
Status:
COMPLETED
Status Verified Date:
2019-09
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 New imaging procedures such as MRI may improve the ability to detect breast tumors
PURPOSE Diagnostic study to determine the value of MRI in detecting breast tumors in women who have had suspicious mammographic or clinical examinations
PURPOSE Diagnostic study to determine the value of MRI in detecting breast tumors in women who have had suspicious mammographic or clinical examinations
Detailed Description:
OBJECTIVES I Evaluate the performance of breast magnetic resonance imaging MRI in conjunction with mammography for the detection and characterization of lesions in women with suspicious mammographic or clinical examinations II Assess the incremental value of breast MRI to determine the local extent of cancer in these patients III Assess the value of breast MRI to determine the prevalence and characteristics of incidental enhancing lesions in the remainder of the breast
OUTLINE This is a multicenter study Patients undergo a high resolution 3D post contrast magnetic resonance imaging MRI scan Patients with enhancing abnormalities undergo a dynamic scan no less than 18 hours later Some patients may require a third scan if a core biopsy is to be performed Patients who are ultimately found to have cancer are assessed for extent of cancer including measurement of the index lesion and identification of other present foci of cancer in relation to the index lesion Further histological diagnosis of index lesions is determined by MRI-guided needle localization excisional biopsy Patients with benign needle biopsy are followed for 2 years Patients with benign primary lesions receive a follow up MRI scan 1 year after the initial scan Patients with benign primary lesions and incidental enhancing lesions IEL are followed at 2 years Patients with negative needle biopsies not yielding a specific diagnosis and who do not undergo subsequent excisional biopsy are followed yearly for 2 years
PROJECTED ACCRUAL A total of 1500 patients will be accrued for this study over 425 years
OUTLINE This is a multicenter study Patients undergo a high resolution 3D post contrast magnetic resonance imaging MRI scan Patients with enhancing abnormalities undergo a dynamic scan no less than 18 hours later Some patients may require a third scan if a core biopsy is to be performed Patients who are ultimately found to have cancer are assessed for extent of cancer including measurement of the index lesion and identification of other present foci of cancer in relation to the index lesion Further histological diagnosis of index lesions is determined by MRI-guided needle localization excisional biopsy Patients with benign needle biopsy are followed for 2 years Patients with benign primary lesions receive a follow up MRI scan 1 year after the initial scan Patients with benign primary lesions and incidental enhancing lesions IEL are followed at 2 years Patients with negative needle biopsies not yielding a specific diagnosis and who do not undergo subsequent excisional biopsy are followed yearly for 2 years
PROJECTED ACCRUAL A total of 1500 patients will be accrued for this study over 425 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UPCC-ACR-6883 | None | None | None |