Predictive MRI Metrics for Tumor Aggressiveness in Papillary Thyroid Cancer

NCT02178345 | Completed

• 1 other identifier: 14-126
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Papillary Thyroid Cancer

Keywords

MRI; 14-126

Outcome Measures

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.

  up to six months

Study Arms (2)

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

diffusion weighted (DW) MRI PROCEDURE

Surgical patients; surveillance management patients

dynamic contrast agent (DCE) MRI PROCEDURE

Surgical patients; surveillance management patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Surgical Head and Neck Cancer clinic MSKCC

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Thyroid Cancer, Papillary

Interventions

Magnetic Resonance Spectroscopy; delta 24-sterol reductase

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Amita Dave, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2014
• First Posted: June 30, 2014
• Study Start: June 24, 2014
• Primary Completion: December 3, 2021
• Study Completion: December 3, 2021
• Last Updated: December 8, 2021

Record last verified: 2021-12

Locations

US (1)