Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107484
Status:
COMPLETED
Last Update Posted:
2010-05-03
First Post:
2005-04-05
Brief Title:
Magnetic Resonance Imaging Using Ferumoxtran-10 in Finding Metastases to the Axillary Lymph Nodes in Patients With Breast Cancer
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Phase II Study of Combidex in Axillary Node Staging in Breast Cancer
Status:
COMPLETED
Status Verified Date:
2010-04
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 Diagnostic procedures such as magnetic resonance imaging MRI using ferumoxtran-10 may help find and diagnose breast cancer that may have spread to the axillary lymph nodes and may help in planning breast cancer treatment
PURPOSE This phase II trial is studying how well MRI using ferumoxtran-10 works in finding metastases to the axillary lymph nodes in patients with invasive breast cancer
PURPOSE This phase II trial is studying how well MRI using ferumoxtran-10 works in finding metastases to the axillary lymph nodes in patients with invasive breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the utility of magnetic resonance MR imaging using ferumoxtran-10 in identifying metastases to the axillary lymph nodes in patients with invasive breast cancer
Secondary
Determine the changes in MR T1 and T2 signal intensity in primary breast tumors after administration of this drug to these patients
Determine the potential of delayed imaging in terms of defining tumor boundaries in these patients
OUTLINE Patients receive ferumoxtran-10 IV over 25-30 minutes on day 0 in the absence of unacceptable toxicity Patients undergo MRI of the involved breast and ipsilateral axilla on day 0 once before and once after ferumoxtran-10 administration and then once on day 1
Within 3 weeks after the completion of imaging studies patients undergo sentinel lymph node biopsy If the sentinel node is positive for malignancy on touch prep an axillary lymph node dissection is performed if clinically indicated
Patients are followed at approximately 1 month after surgery
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study within 83 months
Primary
Determine the utility of magnetic resonance MR imaging using ferumoxtran-10 in identifying metastases to the axillary lymph nodes in patients with invasive breast cancer
Secondary
Determine the changes in MR T1 and T2 signal intensity in primary breast tumors after administration of this drug to these patients
Determine the potential of delayed imaging in terms of defining tumor boundaries in these patients
OUTLINE Patients receive ferumoxtran-10 IV over 25-30 minutes on day 0 in the absence of unacceptable toxicity Patients undergo MRI of the involved breast and ipsilateral axilla on day 0 once before and once after ferumoxtran-10 administration and then once on day 1
Within 3 weeks after the completion of imaging studies patients undergo sentinel lymph node biopsy If the sentinel node is positive for malignancy on touch prep an axillary lymph node dissection is performed if clinically indicated
Patients are followed at approximately 1 month after surgery
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study within 83 months
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 |
|---|---|---|---|
| P30CA016059 | NIH | None | None |
| MCV-4141 | None | None | None |
| NCI-7029 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016059 |