Predictive MRI Metrics for Tumor Aggressiveness in Papillary Thyroid Cancer

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT02178345

Collaborator

(none)

123

Enrollment

Location

89.3

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Papillary Thyroid Cancer	Procedure: diffusion weighted (DW) MRI Procedure: dynamic contrast agent (DCE) MRI

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

123 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Predictive MRI Metrics for Tumor Aggressiveness in Papillary Thyroid Cancer

Actual Study Start Date :

Jun 24, 2014

Actual Primary Completion Date :

Dec 3, 2021

Actual Study Completion Date :

Dec 3, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.	Procedure: diffusion weighted (DW) MRI Procedure: dynamic contrast agent (DCE) MRI
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.	Procedure: diffusion weighted (DW) MRI Procedure: dynamic contrast agent (DCE) MRI

Arm

Intervention/Treatment

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.

Procedure: diffusion weighted (DW) MRI

Procedure: dynamic contrast agent (DCE) MRI

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.

Procedure: diffusion weighted (DW) MRI

Procedure: dynamic contrast agent (DCE) MRI

Outcome Measures

Primary Outcome Measures

feasibility of MRI biomarkers [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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