New MRI Biomarkers in Head and Neck Cancers

Recruiting

• Conditions: Head and Neck Cancer; Thyroid Cancer
• Interventions: Other: MRI examinations

• Registration Number: NCT03483337
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-16
• Study First Submitted: 2018-03-19
• Study First Submitted QC: 2018-03-23
• Study First Posted: 2018-03-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-07
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
head and neck cancer or thyroid cancers (differentiated and undifferentiated)	MRI examinations	All patients, irrespective of treatment regimen, will be imaged on a 1.5T or 3T MR scanner prior to treatment initiation. Follow up imaging for patients undergoing surgery only will be as per clinical standard of care and not on this protocol. Patients undergoing treatment in radiation oncology and/or medicine will have imaging studies during week 2 of treatment. If patients receive 70Gy, they will also receive a scan during week 4 of treatment, if needed by treating physician. Scans will be performed to derive MRI biomarkers indicative of therapeutic mechanisms of action or efficacy will also be performed.
recurrent or metastatic head and neck cancer patients	MRI examinations	Patients will be imaged on a 1.5 T or 3 T MR scanner. Patients will receive a test-retest DWI scan in on session prior to start of treatment. Patients who will be receiving radiation therapy treatment at Memorial Sloan Kettering's main campus, will also be imaged weekly during their course of treatment.

Primary Outcome Measures

Name	Time	Method
For group 1: number of patients that have biomarkers that maybe early response to therapy indicators	1 year	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.
For group 2: number of patients response to treatment	1 year	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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States