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

NCT01927887 | Completed Results DMC

• 1 other identifier: 12-132
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Papillary Carcinoma of Thyroid Gland; Metastatic Medullary Thyroid Cancer; Follicular Thyroid Cancer Lymph Node Metastasis

Keywords

Papillary Carcinoma of Thyroid; Follicular thyroid cancer lymph node metastasis; Metastatic medullary thyroid cancer

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy Parameters of Sensitivity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)

  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

  2 Years

• Primary Efficacy Parameters of Specificity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)

  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. Specificity was determined by assessing the percentage of true negative nodes using pathology as a gold standard.

  2 years

Study Arms (1)

Nanoparticle MRI

EXPERIMENTAL

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.

Drug: Ferumoxytol; Device: Nanoparticle MRI

Interventions

Ferumoxytol DRUG

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.

Also known as: iron oxide-ferumoxytol

Nanoparticle MRI

Nanoparticle MRI DEVICE

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.

Nanoparticle MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Thyroid Cancer, Papillary; Carcinoma, Medullary

Interventions

Ferrosoferric Oxide

Condition Hierarchy (Ancestors)

Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals

Results Point of Contact

• Title: Mukesh Harisinghani
• Organization: Massachusetts General Hospital

mharisinghani@partners.org

6176432009

Study Officials

• Mukesh G Harisinghani, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: August 23, 2013
• Study Start: July 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2016
• Last Updated: June 6, 2017
• Results First Posted: June 6, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)