HN-Quest: HN-QUEST: A Study of Head and Neck Imaging Biomarkers
Study Details
Study Description
Brief Summary
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 (CT-based radiation therapy) will receive up to weekly non-contrast MRI 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The purpose of this study is to develop and investigate novel and established MR imaging sequences as predictive and prognostic radiotherapy biomarkers. Radiotherapy is a fundamental treatment modality for Head and Neck Squamous Cell Carcinoma (HNSCC) with a majority of patients receiving radiation as part of their care pathway. Although treatment is effective, there remains a risk of failure particularly in those presenting with locally advanced disease. In addition, significant proportion of patients receiving radiotherapy will suffer long-term side effects related to their treatment. The addition of concurrent chemotherapy improves the efficacy of radiotherapy, but at the cost of increased treatment related toxicity. The treatment related toxicity and risk of treatment failure means there is a compelling clinical need to personalize therapy based on a patient's early response to radiotherapy.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: HNSCC patients Up to 100 HNSCC patients receiving CT-based radiation therapy will receive up to weekly non-contrast MRI scans during treatment. |
Other: MRI
Non-invasive imaging technique that is used to take pictures of organs within the body.
|
| Other: Healthy volunteers and HNSCC patients 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. |
Other: MRI
Non-invasive imaging technique that is used to take pictures of organs within the body.
|
Outcome Measures
Primary Outcome Measures
- Change in hypoxia level during radiotherapy as assessed by fMRI [Baseline, Week 2 and 4 of radiotherapy, Week 6-8 post radiotherapy]
fMRI images will be used to assess tumour hypoxia status for Head and Neck Squamous Cell Carcinoma (HNSCC)
- Change in tumour tissue and microenvironment during radiotherapy as assessed by fMRI [Weekly MRI imaging during radiotherapy (Up to 7 weeks)]
fMRI images will be used to evaluate on treatment tumour response to determine the effect of dose escalation to tumor sub regions using a daily online adaptive radiation treatment approach
Eligibility Criteria
Criteria
Inclusion Criteria for Cancer Patients:
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Age >/= 18 years
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Histologically proven Head and Neck Squamous Cell carcinoma
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Primary or nodal disease > 3cm for biomarker imaging
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ECOG PS 0-2
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Planned for curative surgery or (chemo)radiotherapy
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Willingness to undergo repeat MRI
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Able to receive and understand verbal and written information regarding study and able to give written informed consent
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Adequate renal function: Calculated creatinine clearance >/= 30ml/min
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Be able to lie comfortably on back for 1 hour
Exclusion Criteria for Cancer Patients:
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As judged by investigator evidence of systemic disease that makes unsuitable for study
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Contra-indication for serial MRI scans
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Previous solid tumor treated within last 5 years
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Pregnancy
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History of significant obstructive airway disease
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History of gadolinium contrast allergy
Inclusion Criteria for Healthy Volunteers
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Age >/= 18 years
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Able to receive and understand verbal and written information regarding study and able to give written informed consent
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Willingness to undergo repeat MRI
Exclusion Criteria for Healthy Volunteers
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Unwillingness to sign informed consent
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Contra-indication for MRI
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Underlying significant respiratory disease
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University Health Network, Toronto
Investigators
- Principal Investigator: Andrew McPartlin, MD, Radiation Oncologist
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-5864