MRI Biomarkers for Head and Neck Cancer

(HN-Quest Trial)

Overseen By Rehab Chahin, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Systemic disease, Previous tumor, Pregnancy, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 7 weeks

173 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to use MRI scans (Magnetic Resonance Imaging) to improve treatment for head and neck cancer. It tracks tumor responses to radiation therapy and aids in developing new biomarkers (measurable signals) for better cancer management. Participants with head and neck squamous cell carcinoma planning to receive radiation therapy may be suitable, especially if their tumor exceeds 3 cm. The study also includes healthy volunteers who will undergo MRI scans at various times. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future cancer treatments.

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's best to discuss this with the study team or your doctor.

What prior data suggests that MRI is safe for use in this study?

Research shows that using MRI (magnetic resonance imaging) for head and neck cancer is generally safe. MRI scans use magnets and radio waves to create images and are usually well-tolerated by most people. Unlike CT scans or X-rays, MRIs do not use radiation.

Previous studies have not identified any major safety concerns with MRI use. Some individuals might feel uncomfortable or claustrophobic inside the MRI machine. MRI is a common tool in hospitals to help doctors see inside the body.

For this study, the MRI scans are non-contrast, meaning no dye is used, which enhances safety. This type of MRI is considered low-risk and is a routine part of many medical evaluations. Overall, evidence suggests that MRI is a safe option for both healthy volunteers and patients with head and neck cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of MRI scans as biomarkers for head and neck cancer (HNSCC), which could revolutionize how these cancers are monitored. Unlike traditional CT-based radiation therapy, which focuses on treatment, this trial aims to use MRI to gain detailed insights into tumor changes throughout the treatment process. By capturing non-contrast MRI images at various intervals, researchers hope to better understand tumor response and progress, potentially leading to more personalized and effective treatment strategies. This could ultimately result in more tailored treatment plans and improved outcomes for patients with HNSCC.

What evidence suggests that this trial's treatments could be effective for head and neck cancer?

Research has shown that MRI (magnetic resonance imaging) serves as a useful tool for predicting outcomes in head and neck squamous cell carcinoma (HNSCC). Studies have found that analyzing MRI images can help predict patient survival and cancer recurrence. In this trial, HNSCC patients will receive MRI scans to assess these predictive capabilities. Combining MRI data with other medical information enhances prediction accuracy. This approach helps doctors understand treatment effectiveness for each patient, enabling more personalized treatment plans for those with HNSCC. ^{6 7 8 9 10}

Who Is on the Research Team?

Andrew McPartlin, MD

Principal Investigator

Radiation Oncologist

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Head and Neck Squamous Cell Carcinoma (HNSCC), specifically those with tumors larger than 3cm, who are fit enough for curative surgery or therapy. Participants must understand the study details, consent in writing, have good kidney function, be able to lie on their back for an hour, and agree to multiple MRIs.

Inclusion Criteria

I am scheduled for surgery or therapy aimed at curing my cancer.

Able to receive and understand verbal and written information regarding study and able to give written informed consent

My cancer or its spread is larger than 3cm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CT-based radiation therapy with weekly non-contrast MRI scans

7 weeks

Weekly MRI scans during treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment with a final MRI scan 6-8 weeks post-treatment

6-8 weeks

Final MRI scan

What Are the Treatments Tested in This Trial?

Interventions

• MRI

Trial Overview The HN-QUEST study is testing how well MRI scans work as biomarkers in tracking treatment progress of HNSCC. It has two arms: one where patients get weekly MRIs during CT-based radiation therapy; another split into healthy volunteers getting two MRIs and patients receiving several MRIs before, during, and after chemo/radiotherapy.

How Is the Trial Designed?

Group I: Healthy volunteers and HNSCC patients Experimental Treatment 1 Intervention

Cohort A - Up to 20 healthy volunteers will undergo non-contrast MRI at two time points. Cohort B - Up to 53 patients planned to receive curative (chemo) radiotherapy for HNSCC will undergo two baseline MRI scans, one MRI in week 2 and week 4, and final MRI scan 6-8 weeks after completion of treatment.

Group II: HNSCC patients Experimental Treatment 1 Intervention

Up to 100 HNSCC patients receiving CT-based radiation therapy will receive up to weekly non-contrast MRI scans during treatment.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

Dynamic contrast-enhanced MRI successfully distinguished between tumor and nontumor nodes in the cervical lymph nodes of 21 patients with squamous cell carcinoma, highlighting its potential as a diagnostic tool.

The study identified significant differences in contrast enhancement parameters between tumor and nontumor nodes, suggesting that dynamic imaging can effectively aid in the assessment of cervical lymph node involvement in head and neck cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges in dynamic contrast-enhanced MRI imaging of cervical lymph nodes to detect metastatic disease. Noworolski, SM., Fischbein, NJ., Kaplan, MJ., et al.[2019]

In a study of 34 patients with head and neck squamous cell carcinoma (HNSCC), specific MRI histogram analysis parameters from T1-weighted and T2-weighted images were found to correlate with important histopathological features, such as p53 and VEGF expression, indicating their potential as biomarkers for tumor characteristics.

The study revealed that the correlations between imaging parameters and histopathological features varied significantly between p16-positive and p16-negative tumors, suggesting that these imaging techniques could help tailor treatment strategies based on tumor type.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Histogram Analysis Parameters Derived from Conventional T1- and T2-Weighted Images Can Predict Different Histopathological Features Including Expression of Ki67, EGFR, VEGF, HIF-1α, and p53 and Cell Count in Head and Neck Squamous Cell Carcinoma. Meyer, HJ., Leifels, L., Hamerla, G., et al.[2021]

A prospective feasibility study was conducted to evaluate the use of ferumoxytol as a contrast agent for dynamic contrast-enhanced MRI in patients with node-positive head and neck squamous cell carcinomas (HNSCC) or melanoma, involving five enrolled patients.

The study was prematurely terminated due to an FDA black box warning, but it aimed to provide valuable clinical and imaging data for future research in molecular imaging despite the early halt.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Data from a terminated study on iron oxide nanoparticle magnetic resonance imaging for head and neck tumors. Elhalawani, H., Awan, MJ., Ding, Y., et al.[2021]

In a study of 22 patients with locally advanced head and neck squamous cell carcinoma, multiparametric MRI was effective in evaluating treatment response to induction chemo-immunotherapy, with 68.2% showing a complete pathological response after treatment.

A machine learning model using dynamic contrast-enhanced (DCE) MRI parameters was able to predict treatment response with a sensitivity of 78.7% and specificity of 78.6%, indicating its potential as a reliable tool for assessing therapy effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive Value of Multiparametric MRI for Response to Single-Cycle Induction Chemo-Immunotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma. Hellwig, K., Ellmann, S., Eckstein, M., et al.[2022]

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]

This systematic review analyzed 58 studies and found that MRI can effectively predict tumor biology in head and neck squamous cell carcinoma (HNSCC), particularly showing that HPV-positive tumors have lower ADCmean and ADCminimum values, indicating a link between these values and tumor characteristics.

The study suggests that MRI can provide rapid and non-invasive insights into tumor biology, which could improve clinical outcomes and personalized treatment strategies for patients with HNSCC, although further research with larger, more uniform datasets is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Prediction of Biological Features Using Magnetic Resonance Imaging in Head and Neck Squamous Cell Carcinoma: A Systematic Review and Meta-Analysis. van der Hulst, HJ., Jansen, RW., Vens, C., et al.[2023]

In a study of 74 patients with head and neck squamous cell carcinoma, the choline/creatine ratio (Cho/Cr) was positively correlated with cyclooxygenase 2 and epidermal growth factor receptor levels, suggesting that these MRI parameters may reflect tumor biology.

The apparent diffusion coefficient (ADC) showed a negative correlation with human epidermal growth factor receptor 2 in metastatic lymph nodes, indicating that ADC could provide insights into tumor aggressiveness and treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation of biomarkers in head and neck squamous cell carcinoma. Tse, GM., King, AD., Yu, AM., et al.[2018]

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]

Baseline magnetic resonance imaging (b-MRI) radiomic features can effectively predict disease recurrence and survival outcomes in patients with head and neck squamous cell carcinoma (HNSCC), with a sensitivity of 82% and specificity of 78% in the training set.

Combining radiomic features with traditional clinical factors (like TNM staging) significantly enhances prognostic accuracy for 5-year disease-free survival and overall survival, indicating that radiomics can provide valuable insights beyond standard clinical assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic role of pre-treatment magnetic resonance imaging (MRI)-based radiomic analysis in effectively cured head and neck squamous cell carcinoma (HNSCC) patients. Alfieri, S., Romanò, R., Bologna, M., et al.[2022]

Citations

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The Prediction of Biological Features Using Magnetic ... The prediction of biological features using magnetic resonance imaging in head and neck squamous cell carcinoma: a systematic review and meta-analysis.

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MRI radiomics in head and neck cancer from ... This study aimed to identify and replicate published, reproducible radiomic signatures based on magnetic resonance imaging (MRI), for prognosis of overall ...

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Improving outcome prediction in oropharyngeal carcinoma ... Combining clinical and radiomic data resulted in a C-index of 0.72 (0.65–0.80), with GLCM-correlation, disease stage and alcohol use as significant predictors.

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Magnetic Resonance Guided Radiotherapy for Head and ... Thus, the existing limited data suggest that the use of MRgRT to adapt treatment for HNSCC is safe and feasible; however, it remains unknown ...

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Magnetic Resonance Imaging (MRI) in the Assessment of ... No prior surgery, chemotherapy or radiation therapy for head and neck cancer; Scheduled to receive chemoradiation for definitive therapy.

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Magnetic Resonance Imaging Contraindications - NCBI - NIH Each implant or device must be verified through a certified MRI safety database or the manufacturer's documentation. Radiologists and ...

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Clinical validation of a prognostic preclinical magnetic ... Clinical validation of a prognostic preclinical magnetic resonance imaging biomarker for radiotherapy outcome in head-and-neck cancer. René M.