Pre-Operative Nodal Staging of Thyroid Cancer Using Ultra-Small Superparamagnetic Iron Oxide Magnetic Resonance Imaging (USPIO MRI): Preliminary Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Primary Efficacy Parameters of Sensitivity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Ferumoxytol (Drug)
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.
干预措施: Nanoparticle MRI (Device)
结局指标
主要结局
Primary Efficacy Parameters of Sensitivity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)
时间窗: 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
Primary Efficacy Parameters of Specificity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)
时间窗: 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. Specificity was determined by assessing the percentage of true negative nodes using pathology as a gold standard.
次要结局
未报告次要终点
研究者
Mukesh Harisinghani, MD
Principal Investigator
Massachusetts General Hospital