Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058058
Status:
COMPLETED
Last Update Posted:
2019-07-16
First Post:
2003-04-07
Brief Title:
Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer
Sponsor:
American College of Radiology Imaging Network
Organization:
American College of Radiology Imaging Network
Study Overview
Official Title:
MRI Evaluation Of The Contralateral Breast In Women With Recent Diagnosis Of Breast Cancer
Status:
COMPLETED
Status Verified Date:
2019-07
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:
ACRIN-6667
Brief Summary:
RATIONALE Diagnostic procedures such as magnetic resonance imaging MRI may improve the ability to detect cancer in the unaffected breast of women recently diagnosed with unilateral breast cancer
PURPOSE Diagnostic trial to determine the effectiveness of MRI in evaluating the unaffected breast of women recently diagnosed with unilateral breast cancer
PURPOSE Diagnostic trial to determine the effectiveness of MRI in evaluating the unaffected breast of women recently diagnosed with unilateral breast cancer
Detailed Description:
OBJECTIVES
Determine the diagnostic yield of magnetic resonance imaging MRI in evaluating the contralateral breast of women with a recent unilateral diagnosis of breast cancer and a negative contralateral mammogram and clinical breast exam
Determine the sensitivity specificity positive predictive value for both call backs for additional imaging and biopsy recommendations and receiver operating characteristic curves of MRI in evaluating these patients
Determine the effect of the following patient-related factors age 50 years old and over vs less than 50 years old breast parenchymal density fatty vs non fatty breast and tumor histology invasive lobular vs invasive ductal invasive vs in situ on the performance of MRI cancer yield sensitivity specificity and PPV
OUTLINE This is a multicenter study
Patients receive gadopentetate dimeglumine IV and then undergo magnetic resonance imaging of the contralateral breast
Patients are followed at 12-18 and 24-30 months
PROJECTED ACCRUAL A total of 1000 patients will be accrued for this study
Determine the diagnostic yield of magnetic resonance imaging MRI in evaluating the contralateral breast of women with a recent unilateral diagnosis of breast cancer and a negative contralateral mammogram and clinical breast exam
Determine the sensitivity specificity positive predictive value for both call backs for additional imaging and biopsy recommendations and receiver operating characteristic curves of MRI in evaluating these patients
Determine the effect of the following patient-related factors age 50 years old and over vs less than 50 years old breast parenchymal density fatty vs non fatty breast and tumor histology invasive lobular vs invasive ductal invasive vs in situ on the performance of MRI cancer yield sensitivity specificity and PPV
OUTLINE This is a multicenter study
Patients receive gadopentetate dimeglumine IV and then undergo magnetic resonance imaging of the contralateral breast
Patients are followed at 12-18 and 24-30 months
PROJECTED ACCRUAL A total of 1000 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| U01CA080098 | NIH | American College of Radiology Imaging Network | httpsreporternihgovquickSearchU01CA080098 |
| ACRIN-6667 | OTHER | None | None |
| U01CA079778 | NIH | None | None |