Diffusion MRI for Head and Neck Cancer

Recruiting at 1 trial location

Overseen By Justin Moore

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Pacemakers, Seizures, Dialysis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how diffusion MRI, an advanced imaging type, can assess treatment effectiveness for head and neck cancer. It examines how this imaging method detects tumor changes during and after standard chemoradiation therapy. The trial has two parts: one monitors patients over time to evaluate how well the imaging predicts treatment success, and the other aims to enhance the imaging technique itself. Suitable candidates for this trial include those with head and neck cancer that has spread to lymph nodes and who have not yet started treatment. As an unphased trial, this study provides a unique opportunity to advance imaging techniques that could improve cancer treatment outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that diffusion MRI is safe for assessing treatment response in head and neck cancer?

Research has shown that diffusion MRI is generally safe for people. Unlike some other imaging methods, it does not expose patients to radiation. Studies have found that diffusion MRI can be used without increasing the risk of immediate unexpected problems after treatment, making it a well-tolerated option for patients. So far, the reviewed studies have reported no serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of diffusion MRI (dMRI) as a new way to predict and monitor treatment response in head and neck cancer. Unlike traditional imaging methods, which might not detect changes early on, dMRI has the potential to show how a tumor is reacting to treatment much sooner. This could lead to more personalized treatment plans and better outcomes for patients. Additionally, optimizing dMRI techniques could improve the assessment of cell viability and metabolism, providing deeper insights into the effectiveness of therapies.

What evidence suggests that diffusion MRI is effective for assessing treatment response in head and neck cancer?

Research shows that diffusion MRI (dMRI) effectively checks how well treatments for head and neck cancer work. In this trial, one arm will focus on longitudinal monitoring using dMRI to assess treatment response in patients undergoing standard-of-care chemoradiation therapy. Studies have found that certain measurements from dMRI, like the diffusion coefficient and diffusional kurtosis coefficient, indicate cell health and treatment effectiveness. For instance, one study discovered that changes in these measurements could predict a patient's response to chemoradiation therapy. Another study confirmed that dMRI reliably assesses tumor response and outcomes. This suggests that dMRI could help detect early on if a treatment is effective for head and neck cancer. ^{3 5 6 7 8}

Who Is on the Research Team?

Elcin Zan, MD

Principal Investigator

NYU Langone

Are You a Good Fit for This Trial?

This trial is for adults with head and neck cancers who haven't started treatment. They must understand the study's key points, which will be explained in their language if needed. Excluded are those with very poor kidney function, pregnant women, people with certain metal implants or electrical devices in their body, or a history of seizures.

Inclusion Criteria

I have head and neck cancer with spread to lymph nodes and haven't started treatment.

I have HNSCC with metastatic lymph nodes and haven't received any treatment yet.

I am able to understand and agree to the study's requirements.

Exclusion Criteria

My kidney function is not severely reduced, and I am not on dialysis.

I have a history of seizures.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo standard-of-care chemoradiation therapy with bi-weekly dMRI scans to monitor tumor response

6 weeks

4 dMRI scans

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Standard-of-care follow-up exams

Optimization of Techniques

Optimization of diffusion MRI methods for assessment of cell viability, metabolism, and perfusion

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Diffusion MRI

Trial Overview

The study tests how well diffusion MRI (dMRI), including PET/MRI with FDG and MRI with gadolinium contrast, can assess cancer treatment response by measuring changes at a microscopic level within tumors.

How Is the Trial Designed?

Group I: Optimization of Techniques Experimental Treatment 2 Interventions

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.

Group II: : Longitudinal Monitoring Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

Post-treatment ADC values from diffusion-weighted imaging (DWI) are significantly correlated with locoregional failure in head and neck squamous cell carcinoma (HNSCC), indicating its potential as a predictive marker.

Monitoring serial changes in ADC values during treatment provides even stronger predictive accuracy for locoregional failure, achieving 100% specificity and 90% accuracy when assessing early or late changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Squamous cell carcinoma of the head and neck: diffusion-weighted MR imaging for prediction and monitoring of treatment response. King, AD., Mo, FK., Yu, KH., et al.[2022]

Quantitative diffusion MRI offers significant advantages over conventional anatomical MRI in patients with head and neck cancer by improving the identification of primary malignant tissues and differentiating tumor types.

This advanced imaging technique can also aid in predicting patient prognosis, monitoring treatment responses, and evaluating changes after treatment, enhancing overall patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative diffusion magnetic resonance imaging in head and neck tumors. Payabvash, S.[2022]

Diffusion-weighted (DW) magnetic resonance imaging (MRI) demonstrated significantly higher sensitivity (84%) and accuracy (91%) in detecting metastatic lymph nodes in head and neck squamous cell carcinoma compared to turbo spin-echo MRI, which had only 7% sensitivity.

The study established an optimal apparent diffusion coefficient (ADC) threshold of 0.94 x 10(-3) mm²/sec for distinguishing between malignant and benign lymph nodes, highlighting DW imaging's effectiveness, especially for subcentimeter nodal metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Head and neck squamous cell carcinoma: value of diffusion-weighted MR imaging for nodal staging. Vandecaveye, V., De Keyzer, F., Vander Poorten, V., et al.[2019]

The study assessed the repeatability of apparent diffusion coefficients (ADC) from diffusion-weighted MRI in 11 head and neck cancer patients during radiotherapy, showing reasonable repeatability for future clinical applications.

Mean ADC values for various tissues (like parotid glands and tumors) were consistent across test/retest scans, with high intraclass correlation coefficients (ICCs), indicating that DW-MRI can reliably inform personalized radiotherapy planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repeatability of diffusion-weighted magnetic resonance imaging in head and neck cancer at a 1.5 T MR-Linac. Habrich, J., Boeke, S., Nachbar, M., et al.[2022]

This review highlights the potential of real-time MR imaging during radiotherapy to monitor changes in organs at risk (OARs) without additional patient burden, which could improve treatment safety and efficacy.

The analysis focused on head and neck cancer patients and included various MRI techniques to assess RT-induced changes in normal tissues, emphasizing the need for more studies with repetitive MRI to better understand the correlation between these changes and treatment toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive MRI of organs at risk in head and neck cancer patients undergoing radiotherapy. Stieb, S., Elgohari, B., Fuller, CD.[2020]

Diffusion-weighted MRI (DWI) can predict treatment outcomes in head and neck squamous cell carcinoma (HNC) during chemoradiotherapy, with significant differences in the DeltaADC values between lesions that recurred and those that achieved complete remission, based on a study of 30 patients.

The study found that changes in DeltaADC were strongly correlated with 2-year locoregional control, making DWI a more effective tool for monitoring treatment response compared to traditional anatomical imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive value of diffusion-weighted magnetic resonance imaging during chemoradiotherapy for head and neck squamous cell carcinoma. Vandecaveye, V., Dirix, P., De Keyzer, F., et al.[2022]

The study highlights the potential of using diffusion-weighted imaging (DWI) as an imaging biomarker to predict treatment response in head and neck squamous cell carcinoma (HNSCC) during radiation therapy, which could help personalize treatment plans.

By integrating MRI with radiation therapy through the MR-Linac system, the research provides a valuable dataset that can enhance understanding of how sequential DWI changes correlate with patient outcomes, potentially improving long-term function and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weekly Intra-Treatment Diffusion Weighted Imaging Dataset for Head and Neck Cancer Patients Undergoing MR-linac Treatment. El-Habashy, DM., Wahid, KA., Renjie, H., et al.[2023]

In a study of 55 patients with mucosal head and neck carcinoma, changes in tumor imaging using diffusion-weighted imaging (DWI) MRI and FDG-PET/CT during radiotherapy were found to be effective predictors of treatment response, particularly at week 3 of treatment.

The combination of changes in DWI and FDG-PET parameters significantly improved the prediction of local recurrence rates, with patients categorized as having favorable imaging responses showing a 0% local recurrence rate compared to 78% in those with unfavorable responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in serial multiparametric MRI and FDG-PET/CT functional imaging during radiation therapy can predict treatment response in patients with head and neck cancer. Trada, Y., Keall, P., Jameson, M., et al.[2023]

Diffusion weighted magnetic resonance imaging (DW-MRI) demonstrated high accuracy in distinguishing persistent or recurrent head and neck squamous cell carcinoma (HNSCC) from non-tumoral changes after treatment, with an impressive sensitivity of 94.6% and specificity of 95.9%.

Compared to other imaging methods like computed tomography and PET scans, DW-MRI produced fewer false positives, making it a more reliable tool for detecting cancer recurrence and identifying small metastatic lymph nodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of head and neck squamous cell carcinoma with diffusion weighted MRI after (chemo)radiotherapy: correlation between radiologic and histopathologic findings. Vandecaveye, V., De Keyzer, F., Nuyts, S., et al.[2021]

Diffusion-weighted imaging (DWI) effectively assesses treatment response in head and neck squamous cell carcinoma (HNSCC) just three weeks after chemoradiotherapy, showing significant differences in apparent diffusion coefficient (ADC) changes between responding and non-responding lesions.

DWI demonstrated high predictive values for treatment outcomes, with a positive predictive value (PPV) of 89% and a negative predictive value (NPV) of 100% for primary lesions, outperforming conventional anatomical imaging methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diffusion-weighted magnetic resonance imaging early after chemoradiotherapy to monitor treatment response in head-and-neck squamous cell carcinoma. Vandecaveye, V., Dirix, P., De Keyzer, F., et al.[2022]

Diffusion-weighted imaging (DWI) sequences on an MR-linac system showed comparable performance to those on a traditional MR simulator, indicating their potential for monitoring treatment response in head and neck cancers.

The study involved 20 participants (10 cancer patients and 10 healthy volunteers) and demonstrated good repeatability and reproducibility of DWI measurements, suggesting that these imaging techniques could be reliable for clinical use in adaptive radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective evaluation of in vivo and phantom repeatability and reproducibility of diffusion-weighted MRI sequences on 1.5 T MRI-linear accelerator (MR-Linac) and MR simulator devices for head and neck cancers. McDonald, BA., Salzillo, T., Mulder, S., et al.[2023]

In a study of 16 patients with head and neck squamous cell carcinoma, a significant inverse correlation was found between the apparent diffusion coefficient (ADC) and tumor cell density, nuclear area, and nuclear-cytoplasmic ratio, indicating that higher cellularity is associated with lower ADC values.

The study also revealed a positive correlation between ADC and the percentage area of stroma, suggesting that the presence of stromal components in tumors may influence ADC readings and could be a factor in predicting local treatment failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diffusion-weighted MR imaging in laryngeal and hypopharyngeal carcinoma: association between apparent diffusion coefficient and histologic findings. Driessen, JP., Caldas-Magalhaes, J., Janssen, LM., et al.[2014]

The study successfully demonstrated the feasibility of using simultaneous 18F-FDG-PET/MRI, including diffusion-weighted imaging and dynamic contrast-enhanced MRI, in 17 patients with head and neck squamous cell cancer, allowing for comprehensive imaging of tumor characteristics.

Significant correlations were found between various imaging parameters, such as glucose metabolism (SUVmean) and microcirculatory parameters (Ktrans and kep), indicating that this integrated imaging approach can provide valuable insights into tumor biology and treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In Vivo Correlation of Glucose Metabolism, Cell Density and Microcirculatory Parameters in Patients with Head and Neck Cancer: Initial Results Using Simultaneous PET/MRI. Gawlitza, M., Purz, S., Kubiessa, K., et al.[2018]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12530915/

A Systematic Review and Meta-analysis

The Relationship Between Functional Parameters Derived from Diffusion-Weighted MRI and 18F-Fluorodeoxyglucose PET/CT in Head and Neck Squamous ...

2.

nature.com

nature.com/articles/s41597-024-03217-z

Dataset of weekly intra-treatment diffusion weighted ...

This data descriptor offers a valuable repository for weekly intra-treatment diffusion-weighted imaging (DWI) data obtained from head and neck cancer patients.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2673914/

Diffusion weighted MRI for predicting and detecting early ...

These results suggest that ADC can be used as a marker for prediction and early detection of response to concurrent chemoradiation therapy in HNSCC.

4.

thegreenjournal.com

thegreenjournal.com/article/S0167-8140(23)00179-2/fulltext

Prospective validation of diffusion-weighted MRI as a ...

Prospective validation of diffusion-weighted MRI as a biomarker of tumor response and oncologic outcomes in head and neck cancer

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S240563082500151X

Patterns of response in head and neck cancer subregions ...

These studies have primarily evaluated changes in diffusion and perfusion parameters, with the goal of assessing treatment response or ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9776484/

Quantitative Diffusion-Weighted Imaging Analyses to ...

This study sought to correlate DWI parameters with treatment response early after immunotherapy treatment in HNSCC.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12374404/

DWI-guided DP-IMRT and conventional MRI-based IMRT in ...

DWI-guided dose escalation has a benefit in DFS for patients with HNSCC without increasing acute adverse events. Keywords: Head and neck ...

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withpower.com

withpower.com/trial/phase-head-and-neck-neoplasms-9-2019-74c33

Diffusion MRI for Head and Neck Cancer

It is generally considered safe, as it does not involve radiation exposure like some other imaging techniques. Show more.