Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147238
Status:
TERMINATED
Last Update Posted:
2012-08-07
First Post:
2005-09-06
Brief Title:
A Validation Study of MR Lymphangiography Using SPIO a New Lymphotropic Superparamagnetic Nanoparticle Contrast
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Validation Study of MR Lymphangiography Using SPIO a New Lymphotropic Superparamagnetic Nanoparticle Contrast
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated at request of sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to evaluate how well ferumoxtran-10 a new Magnetic Resonance Imaging MRI contrast agent can detect cancer in the pelvic lymph nodes or malignant pelvic lymph nodes
Detailed Description:
The contrast agent ferumoxtran-10 is made of ultra small iron oxide particles USPIO Once they are injected through vein they are taken up mostly by liver spleen bone marrow and lymph nodes It takes about 24 - 36 hours to reach peak uptake in the lymph nodes The ability of current imaging techniques to detect the lymph nodes disease is known to be less than perfect Current techniques only use anatomic information size Previous studies have shown that this new contrast agent may be able to detect normal and abnormal lymph nodes using MRI procedure called MRI lymphangiogram This new contrast agent is being evaluated to determine whether it can be used to detect normal and abnormal lymph nodes
The study includes 2 parts The first part will involve you receiving a MRI examination before the contrast is injected The second part will involve you receiving a MRI examination about 24 hours after the injection It will take about 20 minutes for each part
If you are already scheduled to have a routine pelvic MRI the first part of this study will be added at the end of the routine MRI You will then be asked to return next day to complete the second part of the MRI If you are not already scheduled to receive a MRI as part of your standard of care you will come in to the MRI suite at M D Anderson and complete both parts over about a 24-hour interval
You will be lying on the MRI examination table during the scanning At the end of the first part of the study the contrast will be infused slowly through vein over about 30 minutes in the recovery area You will then be observed for 30 minutes to 2 hours depending on your tolerance to the contrast agent The images taken during the first part will be then be repeated 24-36 hours later You will receive a follow-up telephone call from a member of the study staff on Day 3
Once the second part of the MRI is performed your participation in this study will be over
This is an investigational study This contrast agent is currently being evaluated by FDA and has not been approved yet A total of 80 patients will take part in this study All will be enrolled at M D Anderson
The study includes 2 parts The first part will involve you receiving a MRI examination before the contrast is injected The second part will involve you receiving a MRI examination about 24 hours after the injection It will take about 20 minutes for each part
If you are already scheduled to have a routine pelvic MRI the first part of this study will be added at the end of the routine MRI You will then be asked to return next day to complete the second part of the MRI If you are not already scheduled to receive a MRI as part of your standard of care you will come in to the MRI suite at M D Anderson and complete both parts over about a 24-hour interval
You will be lying on the MRI examination table during the scanning At the end of the first part of the study the contrast will be infused slowly through vein over about 30 minutes in the recovery area You will then be observed for 30 minutes to 2 hours depending on your tolerance to the contrast agent The images taken during the first part will be then be repeated 24-36 hours later You will receive a follow-up telephone call from a member of the study staff on Day 3
Once the second part of the MRI is performed your participation in this study will be over
This is an investigational study This contrast agent is currently being evaluated by FDA and has not been approved yet A total of 80 patients will take part in this study All will be enrolled at M D Anderson
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