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New MRI Biomarkers in Head and Neck Cancers

Quantitative Imaging Tools to Derive DW-MRI Oncological Biomarkers

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03483337
Enrollment
200
Registered
2018-03-30
Start date
2018-03-16
Completion date
2027-03-01
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer, Thyroid Cancer

Keywords

(DW)-MRI, oncological biomarkers, metastatic, recurrent, 18-063

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.

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.

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
For group 1: number of patients that have biomarkers that maybe early response to therapy indicators1 yearThe 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 treatment1 yearwill 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.

Countries

United States

Contacts

CONTACTAmita Dave, PhD
davea@mskcc.org212-639-3184
CONTACTAlan Ho, MD, PhD
646-608-3774
PRINCIPAL_INVESTIGATORAmita Dave, PhD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 15, 2026