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:

  • Primary efficacy parameters of ensitivity and specificity of high resolution magnetic resonance imaging with lymphotrophic superparamagnetic nanoparticles (LSN MRI) [ Time Frame: 2 Years ]
    Using pathology as the gold standard the excised nodes will be correlated to histopathologic assessment and the primary efficacy parameters of LSN MRI will be determined for nodal staging
  • Identification of small and otherwise undetectable lymph node metastases in patients with primary or recurrent papillary or medullary thyroid cancer who are scheduled for surgical resection. [ Time Frame: 2 Years ]
    The regional localization of lymph nodes on LSN MRI will be correlated to surgical resection and nodes
  • Assess the presence of histologically positive lymph nodes outside of the usual field of surgical resection. [ Time Frame: 2 Years ]
    Likely metastastic nodes identified on LSN MRI outside the field of surgical resection will be resected at time of surgery and correlated to histopathology


    • 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