Predictive MRI Metrics for Tumor Aggressiveness in Papillary Thyroid Cancer

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.

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Key information

Conditions

Papillary Thyroid Cancer Adenocarcinoma Adenocarcinoma, Papillary Carcinoma Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Thyroid Cancer, Papillary Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Biopsy proven Papillary Thyroid Cancer (regardless of genotype and including all subtypes such as follicular or mixed papillary follicular) or suspicious for Thyroid Cancer
Thyroidectomy or lobectomy planned as definitive treatment for Thyroid Cancer or patients on active surveillance management approach
Age ≥18 years

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

Pacemaker
Aneurysmal clips
Metal implants in field of view
Pregnant
Age and mental status wherein he/she is unable to cooperate for MRI study Patients who have presence of a known contraindication to DCE-MRI may not participate in that portion of the study
Known reaction to Gd-DTPA, contrast agent
Chronic kidney disease
nursing women

Treatment and study plan

diffusion weighted (DW) MRI

Procedure

dynamic contrast agent (DCE) MRI

Procedure

Primary outcomes

feasibility of MRI biomarkers

Time frame: up to six months

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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2021
Study completion: 2021
First posted: Jun 30, 2014
Registry last updated: Dec 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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