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Magnetic resonance imaging (MRI) is a diagnostic technique that takes pictures of organs of the body. It uses magnetic fields and radio waves that cannot be felt. Perfusion MRI uses faster imaging. It also includes a contrast material that is given by vein. This makes specific organs, blood vessels, or tumors easier to see. Diffusion MRI lets us measure the motion of water in the tumor.
Perfusion and diffusion MRI give extra information which is not available with the regular MRI. A regular MRI only shows pictures of the tumor. Thyroid MRI scans are not part of the current standard of care. The purpose of this study is to see if new MRI methods can give us more information about the tumor.
The aim of this pilot study clinical trial is to provide MRI biomarkers as quantitative (surrogate) biomarkers of aggressiveness in papillary thyroid cancer (PTC) including PMCs and to lay out the scientific basis for their translation into patient management. In this study we will perform specially designed diffusion weighted MRI (DW-MRI) and dynamic contrast agent MRI (DCE-MRI) protocols in the PTC patients.
DW-MRI allows for quantifying water diffusion which has been shown to be related to tumor cellularity (29). Particularly, appropriate modeling with DW-MRI data acquired at multiple b values will enable quantifying tumor cellularity and vascularity simultaneously (30-32). DCE-MRI with proper compartmental modeling will yield metrics related to tumor-vessel permeability, tumor perfusion, and extracellular-extravascular volume fraction (33, 34). These facts provide the potential of DW-MRI and DCE-MRI metrics as quantitative imaging biomarkers of tumor aggressiveness in PTCs. The DW-MRI and DCE-MRI may ultimately help in personalized management approach, in which imaging biomarkers may be used to recommend either immediate surgery or active surveillance for PTC patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical patients | The patients will undergo DW-MRI and (if patient is eligible and agrees) DCE-MRI study prior to surgery. The maximum time interval allowed between the MRI study and surgery will be six months. |
| |
| surveillance management patients | The patients will undergo DW-MRI and (if patient is eligible and agrees) DCE-MRI study while being on active surveillance.These patients can also receive the same DW and DCE MRI as a followup a year after the first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diffusion weighted (DW) MRI | Procedure |
| ||
| dynamic contrast agent (DCE) MRI |
| Measure | Description | Time Frame |
|---|---|---|
| feasibility of MRI biomarkers | The long-term goal of this work will be to perform clinical trials of personalized management approach, in which imaging biomarkers are used to recommend either immediate surgery or active surveillance for PTC patients. | up to six months |
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Inclusion Criteria:
Exclusion Criteria:
Patient would require anesthesia for the study
Patients who are claustrophobic Patients with tumor size greater than 5 cm in diameter as measured at imaging (ultrasonography or MRI) before treatment
Patients who have presence of a known contraindication to MRI
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Surgical Head and Neck Cancer clinic MSKCC
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| Name | Affiliation | Role |
|---|---|---|
| Amita Dave, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 17, 2018 | Jun 11, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000077273 | Thyroid Cancer, Papillary |
| ID | Term |
|---|---|
| D000231 | Adenocarcinoma, Papillary |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| C022673 | delta 24-sterol reductase |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Procedure |
|
| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D013964 | Thyroid Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |