Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087347
Status:
COMPLETED
Last Update Posted:
2013-05-14
First Post:
2004-07-08
Brief Title:
Magnetic Resonance Imaging of Lymph Nodes Using Ferumoxytol in Patients With Primary Prostate or Breast Cancer
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
An NCI-Sponsored Exploratory Study For Determining Optimum Timing For The Imaging Of Intravenous Superparamagnetic Particle Ferumoxytol Code7228 For The Differentiation of Metastatic and Non Metastatic Lymph Nodes in Patients With Known Primary Cancer Scheduled For Possible Surgical Lymph Node BiopsyDissection
Status:
COMPLETED
Status Verified Date:
2013-05
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 ferumoxytol may improve the ability to detect cancer that has spread to the lymph nodes and may help plan effective cancer treatment
PURPOSE This clinical trial is studying how well MRI using ferumoxytol works in detecting metastases to the lymph nodes in patients with primary prostate cancer or primary breast cancer
PURPOSE This clinical trial is studying how well MRI using ferumoxytol works in detecting metastases to the lymph nodes in patients with primary prostate cancer or primary breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the range of optimal timing for magnetic resonance imaging of lymph nodes after administration of ferumoxytol in terms of assessing signal intensity using pre-defined pulse sequences in regions of interest and visual criteria in patients with primary prostate or breast cancer who are scheduled to undergo surgical lymph node dissection or sampling
Secondary
Correlate MRI signal intensity with histological findings in patients undergoing this procedure
OUTLINE This is an open-label pilot study
Patients undergo a baseline MRI Within 24 hours after the baseline MRI patients receive ferumoxytol IV over 10-15 seconds or over 1 hour Patients then undergo MRI immediately after ferumoxytol administration at the discretion of the principal investigator and then at 24-28 hours
Patients are followed at 2 weeks
PROJECTED ACCRUAL A total of 10-14 patients 6-8 with prostate cancer and 4-6 with breast cancer will be accrued for this study
Primary
Determine the range of optimal timing for magnetic resonance imaging of lymph nodes after administration of ferumoxytol in terms of assessing signal intensity using pre-defined pulse sequences in regions of interest and visual criteria in patients with primary prostate or breast cancer who are scheduled to undergo surgical lymph node dissection or sampling
Secondary
Correlate MRI signal intensity with histological findings in patients undergoing this procedure
OUTLINE This is an open-label pilot study
Patients undergo a baseline MRI Within 24 hours after the baseline MRI patients receive ferumoxytol IV over 10-15 seconds or over 1 hour Patients then undergo MRI immediately after ferumoxytol administration at the discretion of the principal investigator and then at 24-28 hours
Patients are followed at 2 weeks
PROJECTED ACCRUAL A total of 10-14 patients 6-8 with prostate cancer and 4-6 with breast cancer will be accrued for this study
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-6809 | None | None | None |
| MGH-2004-P-0006812 | None | None | None |