Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003736
Status:
COMPLETED
Last Update Posted:
2019-09-24
First Post:
1999-11-01
Brief Title:
MRI for Detecting Cancer in Women Who Are at High Risk of Developing Breast Cancer
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Abramson Cancer Center at Penn Medicine
Study Overview
Official Title:
Pilot Study High Risk Breast Cancer Screening Pilot Study
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 Screening tests may help doctors detect cancer cells early and plan more effective treatment for breast cancer Diagnostic procedures such as MRI may improve the ability to detect breast cancer
PURPOSE Screening and diagnostic trial to study the effectiveness of MRI scans in women who are at high risk for developing breast cancer
PURPOSE Screening and diagnostic trial to study the effectiveness of MRI scans in women who are at high risk for developing breast cancer
Detailed Description:
OBJECTIVES
Estimate the diagnostic yield and positive predictive value of breast magnetic resonance imaging MRI for the detection of cancer in women who are at greater than 25 lifetime risk for developing breast cancer
Compare the diagnostic yield and positive predictive value of MRI with conventional breast cancer screening mammography and physical examination for the detection of breast cancer in women with a greater than 25 lifetime risk of developing breast cancer
OUTLINE All patients receive a physical exam within 90 days of initial MRI scan Patients undergo a two view screening mammogram within 3 months prior to study entry Patients undergo an MRI with gadolinium contrast at entry All lesions identified as suspicious on physical examination mammography or MRI undergo a core needle or excisional biopsy
PROJECTED ACCRUAL A total of 200 patients will be accrued for this study within 2 years
Estimate the diagnostic yield and positive predictive value of breast magnetic resonance imaging MRI for the detection of cancer in women who are at greater than 25 lifetime risk for developing breast cancer
Compare the diagnostic yield and positive predictive value of MRI with conventional breast cancer screening mammography and physical examination for the detection of breast cancer in women with a greater than 25 lifetime risk of developing breast cancer
OUTLINE All patients receive a physical exam within 90 days of initial MRI scan Patients undergo a two view screening mammogram within 3 months prior to study entry Patients undergo an MRI with gadolinium contrast at entry All lesions identified as suspicious on physical examination mammography or MRI undergo a core needle or excisional biopsy
PROJECTED ACCRUAL A total of 200 patients will be accrued for this study within 2 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 -IBMC-6884 | None | None | None |
| UPCC-ACR-6884 | None | None | None |