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NCT01927887 · ClinicalTrials.gov registry record · NA
Pre-Operative Nodal Staging of Thyroid Cancer Using USPIO MRI: Preliminary Study
A NA study of Metastatic Medullary Thyroid Cancer and Papillary Carcinoma of Thyroid Gland, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT01927887: Completed NA study of Metastatic Medullary Thyroid Cancer and Papillary Carcinoma of Thyroid Gland, sponsored by Massachusetts General Hospital.
NCT01927887 is a NA study of Metastatic Medullary Thyroid Cancer and Papillary Carcinoma of Thyroid Gland that has completed, run by Massachusetts General Hospital. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01927887, a NA study of Metastatic Medullary Thyroid Cancer and Papillary Carcinoma of Thyroid Gland, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Ferumoxytol
- DEVICE Nanoparticle MRI
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2012-07 |
| Est. Completion | 2016-04 |
| Phase | NA |
What the finished NCT01927887 record still lists
NCT01927887 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Metastatic Medullary Thyroid Cancer appearing as the primary indexed condition, and to 2 interventions - of which Ferumoxytol is the first listed.
NCT01927887 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01927887 about?
NCT01927887 is a clinical study titled "Pre-Operative Nodal Staging of Thyroid Cancer Using USPIO MRI: Preliminary Study". 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 u...
What is the current status of trial NCT01927887?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2012-07. Estimated completion is 2016-04.
What conditions does trial NCT01927887 study?
This clinical trial studies the following conditions: Metastatic Medullary Thyroid Cancer, Papillary Carcinoma of Thyroid Gland, Follicular Thyroid Cancer Lymph Node Metastasis.
What interventions are being tested in trial NCT01927887?
The interventions under investigation include: Ferumoxytol (DRUG), Nanoparticle MRI (DEVICE).
Who is sponsoring clinical trial NCT01927887?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01927887 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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