Predictive MRI Metrics for Tumor Aggressiveness in Papillary Thyroid Cancer

Papillary Thyroid Cancer Clinical Trial

Official title:

Predictive MRI Metrics for Tumor Aggressiveness in Papillary Thyroid Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02178345
• Other study ID #: 14-126
• Status: Completed
• Start date: June 24, 2014
• Est. completion date: December 3, 2021

Study information

• Verified date: December 2021
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: December 3, 2021
• Est. primary completion date: December 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aggression
• Papillary Thyroid Cancer
• Thyroid Cancer, Papillary
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Procedure:
• diffusion weighted (DW) MRI

• dynamic contrast agent (DCE) MRI

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center