Clinical Trial: Pre-Operative Nodal Staging of Thyroid Cancer Using Ultra-Small Superparamagnetic Iron Oxide Magnetic Resonance Imaging (USPIO MRI): Preliminary Study
Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional
Official Title: Pre-Operative Nodal Staging of Thyroid Cancer Using Ultra-Small Superparamagnetic Iron Oxide Magnetic Resonance Imaging (USPIO MRI): Preliminary Study
Brief Summary:
The purpose of this research study is to see if a specific kind of MRI can identify small and otherwise undetected abnormal lymph nodes in patients with thyroid cancer who are undergoing surgery. The MRI is called Ultra-Small Superparamagnetic Iron Oxide Magnetic Resonance Imaging (USPIO MRI), and uses an experimental contrast agent (ferumoxytol), to try to identify these lymph nodes. The MRI uses magnetic waves to take images (pictures) of the body and is commonly used in medical testing.
Ferumoxytol is FDA approved as an iron replacement product for the treatment of iron deficiency anemia in adult patients with chronic kidney disease.
In this research study, the investigators want to see if Ferumoxytol will help to identify very small metastases that are not usually seen on standard MRI scans. If the use of USPIO MRI with the experimental agent ferumoxytol identifies very small metastases in lymph nodes, your surgeon may decide to remove them. After the surgery, the nodes will be stored and then analyzed to assess the ability of USPIO MRI and ferumoxytol to detect cancer in very small metastases in the lymph nodes.
Detailed Summary:
In this research study each participant will have the study MRI (USPIO MRI) before he/she undergoes surgery. Radiologists (doctors trained to read and understand this test) will review this study MRI. The imaging results will be compared with the pathology reports from the tissue removed during your surgery.
Before the research starts (screening):
After signing this consent form, the participant will be asked to undergo some screening tests or procedures to find out if the participant can be in the research study. These tests and procedures were done as part of regular care and would have been done even if it turns out that the participant does not take part in the research study.
- An tumor assessment by CT (Computerized Tomography) scan or thyroid US (ultrasonography) scans.
- If these tests show that the participant is eligible to participate in the research study, they will begin the study. If the participant does not meet the eligibility criteria, they will not be able to participate in this research study.
- Because women who are pregnant or nursing a baby cannot be in this research study, the participant will have a urine pregnancy test if they are a woman of child bearing potential. The participant cannot be in this research study if they are pregnant or breastfeeding.
- The investigator will also ask if the participant is allergic to iron. Because the study agent contains iron, the participant cannot be in this research study if they have this allergy.
After the screening procedures confirm that the Participant is eligible to participate in the research study:
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Massachusetts General Hospital
Dates:
Date Received: August 20, 2013
Date Started: July 2012
Date Completion: July 2017
Last Updated: September 12, 2016
Last Verified: September 2016