Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039286
Status:
COMPLETED
Last Update Posted:
2015-12-24
First Post:
2002-06-06
Brief Title:
Positron Emission Tomography Before Surgery in Evaluating Women With Primary or Recurrent Breast Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Pilot Study To Assess The Utility Of 18F-Fluorodeoxyglucose Positron Emission Tomography PET In The Pre-Operative Evaluation Of Patients With Primary And Recurrent Breast Carcinoma
Status:
COMPLETED
Status Verified Date:
2015-12
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 Imaging procedures such as positron emission tomography PET may improve the ability to detect the extent of breast cancer
PURPOSE Diagnostic trial to study the effectiveness of PET to detect the extent of breast cancer in women who have primary or recurrent breast cancer
PURPOSE Diagnostic trial to study the effectiveness of PET to detect the extent of breast cancer in women who have primary or recurrent breast cancer
Detailed Description:
OBJECTIVES
Determine the sensitivity specificity and accuracy of fludeoxyglucose F 18 FDG positron emission tomography PET as compared to conventional imaging in determining the extent of disease in women with primary or recurrent breast cancer
Determine how often clinical management and operative intervention plans for patients are altered based on these FDG-PET scan findings
Determine whether FDG-PET results in more accurate detection of disease in these patients
OUTLINE Patients receive fludeoxyglucose F 18 IV Approximately 1 hour later patients undergo positron emission tomography imaging Some patients may undergo a repeat scan in 4-6 months
PROJECTED ACCRUAL 50 with primary disease and 50 with recurrent disease will be accrued for this study within 1-2 years
Determine the sensitivity specificity and accuracy of fludeoxyglucose F 18 FDG positron emission tomography PET as compared to conventional imaging in determining the extent of disease in women with primary or recurrent breast cancer
Determine how often clinical management and operative intervention plans for patients are altered based on these FDG-PET scan findings
Determine whether FDG-PET results in more accurate detection of disease in these patients
OUTLINE Patients receive fludeoxyglucose F 18 IV Approximately 1 hour later patients undergo positron emission tomography imaging Some patients may undergo a repeat scan in 4-6 months
PROJECTED ACCRUAL 50 with primary disease and 50 with recurrent disease will be accrued for this study within 1-2 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 |
|---|---|---|---|
| NCI-G02-2074 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |
| P30CA008748 | NIH | None | None |
| MSKCC-01134 | None | None | None |