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

Trial Summary

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

Research shows that MRI can help predict tumor biology and treatment outcomes in head and neck cancer by analyzing specific features of the tumor, such as its cellular makeup and blood supply. This ability to non-invasively assess the tumor can improve personalized treatment plans and potentially enhance patient outcomes. ^{1 2 3 4 5}

Is MRI safe for use in humans?

MRI (Magnetic Resonance Imaging) is generally considered safe for humans as it is a non-invasive imaging technique that does not use ionizing radiation. However, certain contrast agents used in MRI, like ferumoxytol, have been associated with safety concerns, leading to study terminations due to FDA warnings. ^{1 2 6 7 8}

How does this MRI-based treatment differ from other treatments for head and neck cancer?

This treatment is unique because it uses MRI (magnetic resonance imaging) to identify biomarkers that can predict tumor biology and treatment outcomes in head and neck cancer, allowing for personalized patient management. Unlike traditional treatments, it provides a non-invasive way to assess the tumor's characteristics and response to therapy. ^{1 2 3 7 9}

What is the purpose of this trial?

This is a multi arm, single center, investigator initiated study to investigate online adaptive radiotherapy and biomarker development in patients with newly diagnosed HNSCC (Head and Neck Squamous Cell Carcinoma) receiving curative therapy. The study will consist of two prospective arms. In Arm 1 up to 100 HNSCC patients receiving (CT)RT (computed tomography-based radiation therapy) will receive up to weekly non-contrast MRI (magnetic resonance imaging) scans during treatment. Arm 2 consists of two cohorts. In cohort A up to 20 healthy volunteers will undergo non-contrast MRI at two time points. In 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.

Research Team

Andrew McPartlin, MD

Principal Investigator

Radiation Oncologist

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. England 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. [2022]

2. Switzerland 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. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

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

4. United States 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. [2021]

5. Switzerland 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Data from a terminated study on iron oxide nanoparticle magnetic resonance imaging for head and neck tumors. [2021]

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

Challenges in dynamic contrast-enhanced MRI imaging of cervical lymph nodes to detect metastatic disease. [2019]

8. 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]

9. England pubmed.ncbi.nlm.nih.gov

Correlation of biomarkers in head and neck squamous cell carcinoma. [2018]