Head Cancer NeckNCT04251481
Diffusion MRI for Head and Neck Cancer
A study testing PET/MRI with FDG, MRI scan without contrast and MRI with gadolinium in people with Head Cancer Neck, run by NYU Langone Health at 2 sites in United States.
Trial summary
The proposed study is to investigate the feasibility of using quantitative diffusion MRI (dMRI) methods for accurate and comprehensive assessment of treatment response. dMRI is a powerful tool to probe treatment-induced change in tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head Cancer Neck
- What is being tested?
- PET/MRI with FDG, MRI scan without contrast and MRI with gadolinium
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Oct 2019to 30 Apr 2026
- Phase
- Interventional
- 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
Who may be able to join
- ARM 1
- Treatment-naïve HNSCC patients with metastatic lymph nodes prior to surgery or chemoradiation therapy
- Age 18 or older
- Subjects without capacity to consent will not be enrolled.
- Subjects will be asked to verbalize understanding of the key elements, for non-English speaking patients, institutional translation services will be utilized.
- ARM 2
Show all 10Show fewer
- Treatment-naïve HNSCC patients with metastatic lymph nodes who will undergo standard-of-care chemoradiation therapy
- Age 18 or older
- Subjects without capacity to consent will not be enrolled.
- Subjects will be asked to verbalize understanding of the key elements, for non-English speaking patients, institutional translation services will be utilized.
Who cannot join
- Subjects who have the following contraindications to MRI:
- Electrical implants such as cardiac pacemakers or perfusion pumps
- Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants
- History of seizures
- Patients with GFR < 15 ml/min/1.73m2 or who are on dialysis will be excluded from the study.
- Subjects who are pregnant
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NYU Langone
New York, New York, 10016
Weill Cornell Medical College
New York, New York, 10065
About this study
Official title: Assessment of the Role of Diffusion MRI Changes During Chemoradiation Treatment of Head and Neck Cancer
The proposed study is to investigate the feasibility of using quantitative diffusion MRI (dMRI) methods for accurate and comprehensive assessment of treatment response. dMRI is a powerful tool to probe treatment-induced change in tumors. It is a unique in vivo imaging technique sensitive to cellular microstructures at the scale of water diffusion length on the order of a few microns. Previous studies have shown that both diffusion coefficient D and diffusional kurtosis coefficient K are promising imaging markers of (i) cell viability which can be used for evaluation of early treatment response. However, it is often underappreciated that these dMRI metrics are not fixed constants, but rather functions of the diffusion time t, D(t) and K(t); their t-dependency is determined by tissue properties, such as cell size and membrane permeability of tissue. D(t) and K(t) of tumors can vary substantially depending on t in the range of diffusion times (30-100 ms) typically used in clinical scan.
Read the detailed description
This study will investigate the t-dependency of dMRI over a range of diffusion times (30-500 ms) to determine an optimal diffusion time for treatment response assessment when only one diffusion time needs to be used, particularly in routine clinical studies. Furthermore, the data with multiple diffusion times will also be used to measure the water exchange time of cancer cells. Exchange time has been studied using Dynamic Contrast Enhanced (DCE) MRI by multiple groups including ours, and has been suggested as a marker of (ii) cellular metabolism that regulates the ATP-dependent ion channels co-transporting water molecules. The study will measure with dMRI, without using a contrast agent. The investigators also demonstrated that Intra-Voxel Incoherent Motion (IVIM) MRI metrics (pseudo diffusivity, Dp; perfusion fraction, fp), from multiple b-values at a fixed diffusion time, can be used to assess the perfusion status of tumor and they are also associated with tumor interstitial fluid pressure. The IVIM effect has been observed in various cancer types (33-39) and animal tumor models. The product fp*Dp - a quantity including both blood volume and velocity information - is considered as a parameter analogous to (iii) perfusion flow .
- Conditions
- Head Cancer Neck
- Being tested
- PET/MRI with FDG, MRI scan without contrast, MRI with gadolinium
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MRI with FDGRadiation
For the PET/MRI scans, an intravenous (IV) catheter (thin tube) will be used to administer dyes (contrast) for both the MRI and PET portions of the examination. The dye for the PET portion will be 18F-fluorodeoxyglucose (FDG). FDG is an FDA-approved radioactive substance (isotope) that contains chemicals that can be traced by PET/MRI. The dye for the MRI portion will be a gadolinium based contrast medium which is also an FDA-approved substance that makes certain tissues, abnormalities or disease processes more clearly visible on MRI scans. MRI uses a strong magnetic field to create images of the body. Subjects will be asked to lie on a table that will slide into the scanner; Wear earplugs to reduce the noise made by the MRI scanner and lie still throughout the time in the scanner.
MRI scan without contrastRadiation
MRI uses a strong magnetic field to create images of the body. Subjects will be asked to lie on a table that will slide into the scanner to scan the neck ; Wear earplugs to reduce the noise made by the MRI scanner and lie still throughout the time in the scanner.
MRI with gadoliniumRadiation
For the MRI scans, an intravenous (IV) catheter (thin tube) will be used to administer dyes (contrast) for MR scans. The dye for the MRI will be a gadolinium based contrast medium which is also an FDA-approved substance that makes certain tissues, abnormalities or disease processes more clearly visible on MRI scans. MRI uses a strong magnetic field to create images of the body. Subjects will be asked to lie on a table that will slide into the scanner; Wear earplugs to reduce the noise made by the MRI scanner and lie still throughout the time in the scanner.
| Study group | Role | What they receive |
|---|---|---|
| Optimization of Techniques | Experimental | To optimize the diffusion MRI methods for assessment of cell viability, metabolism and perfusion in head and neck cancer. There will be 24 subjects enrolled for 2 year duration. Treatment-naïve patients with cervical metastatic lymph nodes (diameter > 10 mm) of HNSCC will be recruited to have one research PET/MR scan (including dMRI) and one dMRI-only scan within three days prior to treatment. These data will be used to optimize the dMRI method and assess the repeatability. Receives: Radiation: PET/MRI with FDG; Radiation: MRI scan without contrast |
| : Longitudinal Monitoring | Experimental | To assess the feasibility of using diffusion MRI metrics at early stages of treatment for prediction of treatment response in head and neck cancer patients undergoing standard-of-care chemoradiation therapy. There will be 36 subjects enrolled for 3 year duration. The study will do bi-weekly measurement to monitor tumor response longitudinally. This study will be restricted to treatment-naïve patients who present pathologically confirmed HNSCC with metastatic lymph nodes and who are scheduled to receive standard care of radiation therapy with concurrent chemotherapy. The patients enrolled in this arm of the study will have 4 dMRI scans. The imaging data for each patient will be the proposed dMRI measures at the baseline and their changes at each follow-up time period. DCE-MRI will be included in the baseline scan for tumor delination as in standard-of-care cancer imaging and to compare with the proposed dMRI method. Receives: Radiation: MRI scan without contrast; Radiation: MRI with gadolinium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-class Correlation (ICC)
Estimated components from a random effects model in each dMRI measure will be used to compute intra-class correlation as estimates of repeatability of each measure.
Measured: 6 weeks
Intra-subject Coefficient of Variation (CV)
Estimated components from a random effects model in each dMRI measure will be used to compute intra-subject coefficient of variation as estimates of repeatability of each measure.
Measured: 6 weeks
Overall Response Rate (ORR)
Binary classification of treatment response as complete response (CR) versus partial response (PR) for participants at the end of the chemoradiation therapy assessed by clinical/radiological reports. CR will include the cases with complete disappearance of any clinically detectable tumor mass, while PR will include cases with stable disease and progressive disease.
Measured: 6 weeks
Secondary outcomes (1)
Progression-Free Survival (PFS)
Binary indicator of whether patients showed progression-free survival at 2 years post treatment on the standard-of-care follow-up exams. PFS is the length of time that a patient lives with the disease but it does not get worse.
Measured: 2 Years Post-Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start16 Oct 2019
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head Cancer NeckStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elcin Zan, MD, Principal investigator, NYU Langone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251481
- Sponsor's protocol ID
- 18-01454
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2020
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Role of Diffusion MRI Changes During Chemoradiation Treatment of Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT04251481
- Acronym / sponsor ID
- 18-01454
- Conditions
- Head Cancer Neck
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 5 Feb 2020 (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.
The proposed study is to investigate the feasibility of using quantitative diffusion MRI (dMRI) methods for accurate and comprehensive assessment of treatment response. dMRI is a powerful tool to probe treatment-induced change in tumors. It is a unique in vivo imaging technique sensitive to cellular microstructures at the scale of water diffusion length on the order of a few microns. Previous studies have shown that both diffusion coefficient D and diffusional kurtosis coefficient K are promising imaging markers of (i) cell viability which can be used for evaluation of early treatment response. However, it is often underappreciated that these dMRI metrics are not fixed constants, but rather functions of the diffusion time t, D(t) and K(t); their t-dependency is determined by tissue properties, such as cell size and membrane permeability of tissue. D(t) and K(t) of tumors can vary substantially depending on t in the range of diffusion times (30-100 ms) typically used in clinical scan.
Detailed description
This study will investigate the t-dependency of dMRI over a range of diffusion times (30-500 ms) to determine an optimal diffusion time for treatment response assessment when only one diffusion time needs to be used, particularly in routine clinical studies. Furthermore, the data with multiple diffusion times will also be used to measure the water exchange time of cancer cells. Exchange time has been studied using Dynamic Contrast Enhanced (DCE) MRI by multiple groups including ours, and has been suggested as a marker of (ii) cellular metabolism that regulates the ATP-dependent ion channels co-transporting water molecules. The study will measure with dMRI, without using a contrast agent. The investigators also demonstrated that Intra-Voxel Incoherent Motion (IVIM) MRI metrics (pseudo diffusivity, Dp; perfusion fraction, fp), from multiple b-values at a fixed diffusion time, can be used to assess the perfusion status of tumor and they are also associated with tumor interstitial fluid pressure. The IVIM effect has been observed in various cancer types (33-39) and animal tumor models. The product fp*Dp - a quantity including both blood volume and velocity information - is considered as a parameter analogous to (iii) perfusion flow .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimization of Techniques | Experimental | Radiation: PET/MRI with FDG, Radiation: MRI scan without contrastTo optimize the diffusion MRI methods for assessment of cell viability, metabolism and perfusion in head and neck cancer. There will be 24 subjects enrolled for 2 year duration. Treatment-naïve patients with cervical metastatic lymph nodes (diameter > 10 mm) of HNSCC will be recruited to have one research PET/MR scan (including dMRI) and one dMRI-only scan within three days prior to treatment. These data will be used to optimize the dMRI method and assess the repeatability. |
| : Longitudinal Monitoring | Experimental | Radiation: MRI scan without contrast, Radiation: MRI with gadoliniumTo assess the feasibility of using diffusion MRI metrics at early stages of treatment for prediction of treatment response in head and neck cancer patients undergoing standard-of-care chemoradiation therapy. There will be 36 subjects enrolled for 3 year duration. The study will do bi-weekly measurement to monitor tumor response longitudinally. This study will be restricted to treatment-naïve patients who present pathologically confirmed HNSCC with metastatic lymph nodes and who are scheduled to receive standard care of radiation therapy with concurrent chemotherapy. The patients enrolled in this arm of the study will have 4 dMRI scans. The imaging data for each patient will be the proposed dMRI measures at the baseline and their changes at each follow-up time period. DCE-MRI will be included in the baseline scan for tumor delination as in standard-of-care cancer imaging and to compare with the proposed dMRI method. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ARM 1
- Treatment-naïve HNSCC patients with metastatic lymph nodes prior to surgery or chemoradiation therapy
- Age 18 or older
- Subjects without capacity to consent will not be enrolled.
- Subjects will be asked to verbalize understanding of the key elements, for non-English speaking patients, institutional translation services will be utilized.
Key exclusion criteria (6 listed)
- Subjects who have the following contraindications to MRI:
- Electrical implants such as cardiac pacemakers or perfusion pumps
- Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants
- History of seizures
- Patients with GFR < 15 ml/min/1.73m2 or who are on dialysis will be excluded from the study.
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 |
|---|---|---|
| PET/MRI with FDGFor the PET/MRI scans, an intravenous (IV) catheter (thin tube) will be used to administer dyes (contrast) for both the MRI and PET portions of the examination. The dye for the PET portion will be 18F-fluorodeoxyglucose (FDG). FDG is an FDA-approved radioactive substance (isotope) that contains chemicals that can be traced by PET/MRI. The dye for the MRI portion will be a gadolinium based contrast medium which is also an FDA-approved substance that makes certain tissues, abnormalities or disease processes more clearly visible on MRI scans. MRI uses a strong magnetic field to create images of the body. Subjects will be asked to lie on a table that will slide into the scanner; Wear earplugs to reduce the noise made by the MRI scanner and lie still throughout the time in the scanner. | Radiation | Optimization of Techniques |
| MRI scan without contrastMRI uses a strong magnetic field to create images of the body. Subjects will be asked to lie on a table that will slide into the scanner to scan the neck ; Wear earplugs to reduce the noise made by the MRI scanner and lie still throughout the time in the scanner. | Radiation | : Longitudinal Monitoring, Optimization of Techniques |
| MRI with gadoliniumFor the MRI scans, an intravenous (IV) catheter (thin tube) will be used to administer dyes (contrast) for MR scans. The dye for the MRI will be a gadolinium based contrast medium which is also an FDA-approved substance that makes certain tissues, abnormalities or disease processes more clearly visible on MRI scans. MRI uses a strong magnetic field to create images of the body. Subjects will be asked to lie on a table that will slide into the scanner; Wear earplugs to reduce the noise made by the MRI scanner and lie still throughout the time in the scanner. | Radiation | : Longitudinal Monitoring |
Primary outcome
Intra-class Correlation (ICC)
Time frame: 6 weeks
Estimated components from a random effects model in each dMRI measure will be used to compute intra-class correlation as estimates of repeatability of each measure.
Intra-subject Coefficient of Variation (CV)
Time frame: 6 weeks
Estimated components from a random effects model in each dMRI measure will be used to compute intra-subject coefficient of variation as estimates of repeatability of each measure.
Overall Response Rate (ORR)
Time frame: 6 weeks
Binary classification of treatment response as complete response (CR) versus partial response (PR) for participants at the end of the chemoradiation therapy assessed by clinical/radiological reports. CR will include the cases with complete disappearance of any clinically detectable tumor mass, while PR will include cases with stable disease and progressive disease.
1 secondary outcome
Progression-Free Survival (PFS)
Time frame: 2 Years Post-Treatment
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 22 Jan 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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. This study is not recruiting at the moment.
Elcin Zan, MD principal investigator
NYU Langone
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/MRI with FDG, MRI scan without contrast and MRI with gadolinium in people with Head Cancer Neck, run by NYU Langone Health at 2 sites 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 10 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-class Correlation (ICC) (time frame: 6 weeks). The study lists 3 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 22 Jan 2026.