Trial record 5 of 203 for:    Open Studies | "Lymph Nodes"

Pre-Operative Nodal Staging of Thyroid Cancer Using Ultra-Small Superparamagnetic Iron Oxide Magnetic Resonance Imaging (USPIO MRI): Preliminary Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Mukesh Harisinghani, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01927887
First received: August 20, 2013
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Papillary Carcinoma of Thyroid Metastatic to Regional Lymph Node
Metastatic Medullary Thyroid Cancer
Follicular Thyroid Cancer Lymph Node Metastasis
Drug: Ferumoxytol
Device: lymphotrophic superparamagnetic nanoparticles (LSN MRI).

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pre-Operative Nodal Staging of Thyroid Cancer Using Ultra-Small Superparamagnetic Iron Oxide Magnetic Resonance Imaging (USPIO MRI): Preliminary Study

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Primary efficacy parameters of ensitivity and specificity of high resolution magnetic resonance imaging with lymphotrophic superparamagnetic nanoparticles (LSN MRI) [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Likely metastastic nodes identified on LSN MRI outside the field of surgical resection will be resected at time of surgery and correlated to histopathology


Estimated Enrollment: 20
Study Start Date: July 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lymphotrophic superparamagnetic nanoparticles (LSN 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.
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.
Other Name: iron oxide-ferumoxytol
Device: lymphotrophic superparamagnetic nanoparticles (LSN 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.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01927887

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Mukesh G Harisinghani, M.D.    617-726-2000    Mharisinghani@partners.org   
Principal Investigator: Mukesh G Harisinghani, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Mukesh G Harisinghani, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Mukesh Harisinghani, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01927887     History of Changes
Other Study ID Numbers: 12-132
Study First Received: August 20, 2013
Last Updated: August 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Papillary Carcinoma of Thyroid Metastatic to Regional Lymph Node
Follicular thyroid cancer lymph node metastasis
Metastatic medullary thyroid cancer

Additional relevant MeSH terms:
Carcinoma
Thyroid Neoplasms
Carcinoma, Papillary
Neoplasm Metastasis
Thyroid Diseases
Adenocarcinoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases
Neoplasms, Squamous Cell
Neoplastic Processes
Pathologic Processes
Adenocarcinoma
Lymphoma
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Ferrosoferric Oxide
Iron
Ferumoxtran-10
Ferumoxides
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014