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CompletedNCT02178345Updated Dec 8, 2021

Predictive MRI Metrics for Tumor Aggressiveness in Papillary Thyroid Cancer

An observational study in Papillary Thyroid Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-08.

Sponsored by Memorial Sloan Kettering Cancer Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
123
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Papillary Thyroid Cancer

Keywords

  • MRI
  • 14-126
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In context

Thyroid Neoplasms

802 studies on the registry are indexed under Thyroid Neoplasms; 216 are open to participants now.

This study's enrollment of 123 is below the median of 172 across 261 observational studies indexed under Thyroid Neoplasms.

Browse Thyroid Neoplasms studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Surgical Head and Neck Cancer clinic MSKCC

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
123 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • Procedurediffusion weighted (DW) MRI
  • Proceduredynamic contrast agent (DCE) MRI
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to six months

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Study locations

1 site
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
08

References and documents

Study documents

  • Informed consent form · Jan 17, 2018

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02178345
Lead sponsor
Memorial Sloan Kettering Cancer Center
Responsible party
Sponsor
First posted
Jun 30, 2014
Start date
Jun 24, 2014
Primary completion
Dec 3, 2021
Completion
Dec 3, 2021
Last update
Dec 8, 2021

Study contacts

Amita Dave, PhD
principal investigator · Memorial Sloan Kettering Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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