Pre-Operative Nodal Staging of Thyroid Cancer Using USPIO MRI: Preliminary Study

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Dextrans; Ferric Compounds; Ferrosoferric Oxide; Iron

Criteria

Inclusion Criteria:

• Subjects must have either primary or recurrent PTC or MTC with nodal metastases detected through physical examination and/or standard imaging techniques.

• Subjects must be deemed eligible for resection by a surgeon who is listed as an Investigator in this study;

• Age > 18 years;

• Subjects must be willing and able to understand and sign Informed Consent.

• No uncontrolled serious medical or psychiatric illness.

• Women of childbearing potential must not be pregnant or lactating.

• Subjects will have had standard care CT, MRI, or ultrasound, and a fine-needle aspiration biopsy demonstrating PTC or MTC with nodal metastases or recurrent/persistent nodal disease in a patient with known PTC or MTC.

Exclusion Criteria:

• Subjects who have a known allergy to iron;

• Subjects who are pregnant or lactating;

• Subjects who are less than 18 year of age;

• Subjects with a counter-indication to MRI, such as the presence of metallic prostheses or implanted metal device (e.g., infusion pump, defibrillator)

• Subjects with sickle cell disease, hemoglobinopathy, hemochromatosis or other clinical conditions that may lead to iron overload.

• State a medical or scientific reason if women who are pregnant or nursing will be excluded from the study. Guidelines and procedures pertinent to this requirement are available at: http://ctep.cancer.gov/protocolDevelopment/templates_applications.htm. Suggested text is provided below and may be modified as necessary.

Pregnant women are excluded from this study because there are no studies of ferumoxytol in pregnant women. In animal studies, ferumoxytol caused decreased fetal weights and fetal malformations at maternally toxic doses of 13-15 times the human dose. It is unknown if ferumoxytol is present in human milk. Because of the potential for adverse events in nursing infants, a decision should be made whether to discontinue nursing or to avoid ferumoxytol.

• State a medical or scientific reason if participants who are cancer survivors or those who are HIV positive will be excluded from the study. The full text of the Policies, Guidelines, and Procedures pertinent to this requirement is available at http://ctep.cancer.gov/protocolDevelopment/templates_applications.htm.

Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy.

HIV-positive individuals on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ferumoxytol and the propensity to have inflammatory adenopathy.

-