Diffusion MRI for Head and Neck Cancer

Recruiting at1 trial location

Overseen by Elcin Zan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: NYU Langone Health

Disqualifiers: Pacemakers, Seizures, Dialysis, Pregnancy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Diffusion MRI for head and neck cancer?

Research shows that diffusion-weighted MRI can help predict and monitor how well head and neck cancer responds to treatments like chemoradiotherapy. This imaging technique can differentiate between cancerous and non-cancerous changes after treatment, helping doctors assess the effectiveness of the therapy. ^{1 2 3 4 5}

Is Diffusion MRI safe for humans?

Diffusion MRI, used in studies for head and neck cancer, has been performed on patients without additional risks beyond standard MRI procedures. It is generally considered safe, as it does not involve radiation exposure like some other imaging techniques. ^{6 7 8 9 10}

How does diffusion MRI differ from other treatments for head and neck cancer?

Diffusion MRI is unique because it helps predict and monitor how well head and neck cancer responds to treatment by analyzing how water molecules move in tissues, which can indicate changes in the tumor. This imaging technique provides additional information beyond standard MRI scans, helping doctors differentiate between types of tumors and assess treatment effectiveness. ^{1 2 11 12 13}

Research Team

Elcin Zan, MD

Principal Investigator

NYU Langone

Eligibility Criteria

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 am 18 years old or older.

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.

Exclusion Criteria

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

I have a history of seizures.

Subjects who are pregnant

Trial Timeline

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

Treatment Details

Interventions

• Diffusion MRI (Imaging)

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.

Participant Groups

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+

Dr. Alec C. Kimmelman

NYU Langone Health

Chief Executive Officer

MD and PhD from Mount Sinai School of Medicine

Dr. Nicole M. Adler

NYU Langone Health

Chief Medical Officer since 2023

MD

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Predictive value of diffusion-weighted magnetic resonance imaging during chemoradiotherapy for head and neck squamous cell carcinoma. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Squamous cell carcinoma of the head and neck: diffusion-weighted MR imaging for prediction and monitoring of treatment response. [2022]

3. Germany 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. [2023]

4. United States 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. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Diffusion-weighted magnetic resonance imaging early after chemoradiotherapy to monitor treatment response in head-and-neck squamous cell carcinoma. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

Repetitive MRI of organs at risk in head and neck cancer patients undergoing radiotherapy. [2020]

7. United States 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. [2018]

8. Ireland pubmed.ncbi.nlm.nih.gov

Repeatability of diffusion-weighted magnetic resonance imaging in head and neck cancer at a 1.5 T MR-Linac. [2022]

9. Ireland 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. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Weekly Intra-Treatment Diffusion Weighted Imaging Dataset for Head and Neck Cancer Patients Undergoing MR-linac Treatment. [2023]

11. China pubmed.ncbi.nlm.nih.gov

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

12. United States pubmed.ncbi.nlm.nih.gov

Diffusion-weighted MR imaging in laryngeal and hypopharyngeal carcinoma: association between apparent diffusion coefficient and histologic findings. [2014]

13. United States pubmed.ncbi.nlm.nih.gov

Head and neck squamous cell carcinoma: value of diffusion-weighted MR imaging for nodal staging. [2019]