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

NACompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

April 30, 2015

Study Completion Date

April 30, 2016

Conditions
Papillary Carcinoma of Thyroid GlandMetastatic Medullary Thyroid CancerFollicular Thyroid Cancer Lymph Node Metastasis
Interventions
DRUG

Ferumoxytol

Ferumoxytol will be administered as an undiluted intravenous injection dose of 6 mg/kg body weight, up to a maximum dose of 510 mg, delivered at a rate of up to 1ml/sec. Each ml of the supplied agent contains 30 mg of elemental iron and the dose will be titrated based on patients body weight in kilograms; for example at a dose of 6 mg/kg, the dose for a 50 kg person will be 50 x 6 = 300 mg. As the vial contains 30 mg/ml, 10 cc of the dose will correspond to the required 300 mg dose.

DEVICE

Nanoparticle MRI

Each subject will have one MRI scan. At the initial pre-scan visit, the subject will receive the ferumoxytol infusion. Within 48-72 hours after ferumoxytol infusion, a scan will be performed. Subjects will be imaged at Massachusetts General Hospital using commercial 3.0T imaging systems using dedicated neck coil and approved imaging protocols. The MR imaging will include conventional T1 and T2 weighted spin echo and 3 D gradient echo sequences.

Trial Locations (1)

02114

Massachusetts General Hospital, Boston

All Listed Sponsors
lead

Massachusetts General Hospital

OTHER

NCT01927887 - Pre-Operative Nodal Staging of Thyroid Cancer Using USPIO MRI: Preliminary Study | Biotech Hunter | Biotech Hunter