New MRI Biomarkers in Head and Neck Cancers
Quantitative Imaging Tools to Derive DW-MRI Oncological Biomarkers
1 other identifier
observational
200
1 country
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 16, 2018
CompletedFirst Submitted
Initial submission to the registry
March 19, 2018
CompletedFirst Posted
Study publicly available on registry
March 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
April 14, 2026
April 1, 2026
9 years
March 19, 2018
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (2)
recurrent or metastatic head and neck cancer patients
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.
head and neck cancer or thyroid cancers (differentiated and undifferentiated)
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.
Interventions
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.
Eligibility Criteria
MSK clinics in the medicine, surgery and radiation oncology departments.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amita Dave, PhD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2018
First Posted
March 30, 2018
Study Start
March 16, 2018
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
April 14, 2026
Record last verified: 2026-04