New MRI Biomarkers in Head and Neck Cancers

Head and Neck Cancer Clinical Trial

Official title:

Quantitative Imaging Tools to Derive DW-MRI Oncological Biomarkers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03483337
• Other study ID #: 18-063
• Status: Recruiting
• Start date: March 16, 2018
• Est. completion date: March 2025

Study information

• Verified date: October 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Amita Dave, PhD
• Phone: 212-639-3184
• Email: davea[@]mskcc.org
• 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. This makes specific organs, blood vessels, or tumors easier to see. Diffusion MRI lets us measure the motion of water in the tumor.

The purpose of this study is to see if new MRI methods can give us more information about the tumor.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Group 1 patients: Presence of a suspicious metastatic lesion or suspicious for recurrent disease in the head and neck region.

• Group 2 patients:

• Biopsy proven recurrent or metastatic or definitive head and neck cancer or (differentiated and undifferentiated) thyroid cancers in the head and neck region only.

• Patients planning to undergo reatment at MSK

Exclusion Criteria:

• Patient would require anesthesia for the study

• Patients who are claustrophobic

• Patients selecting treatment outside of MSK

• Known reaction to Gd based contrast agent

• Patients who have presence of a known contradiction to MRI

• Pacemaker

• Aneurysm clips

• Patients with implants that are contradicted for MR imaging will be excluded

• Pregnant

• Age and mental status wherein he /she is unable to cooperate for MRI study

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Thyroid Cancer

Intervention

Other:
• MRI examinations
Patients will be imaged on a 1.5 T or 3 T MR scanner either from GE or Philips. Patients will receive a test-retest scan in on session prior to start of treatment. Patients who will be receiving radiation therapy treatment at main campus, will also be imaged weekly during their course of treatment.
• MRI examinations
Patients will be imaged on a 1.5 T or 3T MR scanner within one week prior to treatment initiation and at two months and four months after treatment completion (+/- 1 week).

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	For group 1: number of patients that have biomarkers that maybe early response to therapy indicators	The study is designed to determine if the MRI will provide quantitative imaging biomarkers to predict or assess early treatment response in R/M head and neck cancers. The MR data will be compared with clinical follow-up data. Additional sequence parameters.	1 year
Primary	For group 2: number of patients response to treatment	will be assessed using ROC curves with RECIST with the RECIST version 1.1 response as the gold standard and change in DW-MRI and image feature metrics as predictors.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center