Head and Neck CancerNCT03483337
New MRI Biomarkers in Head and Neck Cancers
An observational study of Head and Neck Cancer and Thyroid Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Thyroid Cancer
- What is being tested?
- MRI examinations
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2018to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: MSK clinics in the medicine, surgery and radiation oncology departments.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alan Ho, MD, PhD contact
United States1 site, 1 recruiting
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Amita Dave, PhD, 212-639-3184
Alan Ho, MD, PhD, 646-608-3774
About this study
Official title: Quantitative Imaging Tools to Derive DW-MRI Oncological Biomarkers
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.
- Conditions
- Head and Neck Cancer, Thyroid Cancer
- Being tested
- MRI examinations
- Keywords
- (DW)-MRI, oncological biomarkers, metastatic, recurrent, 18-063
- Medical subject headings
- Head and Neck Neoplasms, Thyroid Neoplasms, Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI examinationsOther
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 examinationsOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: MRI examinations | |
| 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. Receives: Other: MRI examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start16 Mar 2018
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amita Dave, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483337
- Sponsor's protocol ID
- 18-063
- Status last verified
- Apr 2026
- First submitted
- 19 Mar 2018
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Imaging Tools to Derive DW-MRI Oncological Biomarkers
- ClinicalTrials.gov ID
- NCT03483337
- Acronym / sponsor ID
- 18-063
- Conditions
- Head and Neck Cancer, Thyroid Cancer
- Keywords
- (DW)-MRI, oncological biomarkers, metastatic, recurrent, 18-063
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 30 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| recurrent or metastatic head and neck cancer patients | – | Other: MRI examinationsPatients 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) | – | Other: MRI examinationsAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MSK clinics in the medicine, surgery and radiation oncology departments.
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI examinationsPatients 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. | Other | recurrent or metastatic head and neck cancer patients |
| MRI examinationsPatients 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). | Other | head and neck cancer or thyroid cancers (differentiated and undifferentiated) |
Primary outcome
For group 1: number of patients that have biomarkers that maybe early response to therapy indicators
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alan Ho, MD, PhD contact
Amita Dave, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Thyroid Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amita Dave, PhD (212-639-3184, davea@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
For group 1: number of patients that have biomarkers that maybe early response to therapy indicators (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.