The purpose of this study is to explore biomarker development in patients with newly diagnosed Head and neck squamous cell carcinoma (HNSCC) receiving curative therapy.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age \>/= 18 years
* Histologically proven Head and Neck Squamous Cell carcinoma
* Primary or nodal disease \> 3cm for biomarker imaging
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
* Planned for curative surgery or (chemo)radiotherapy
* Willingness to undergo repeat MRI imaging
* Able to receive and understand verbal and written information regarding study and able to give written informed consent
* Adequate renal function: Calculated creatinine clearance \>/= 30ml/min
* Be able to lie comfortably on back for 1 hour
Exclusion Criteria:
* As judged by investigator evidence of systemic disease that makes unsuitable for study
* Contra-indication for serial MRI scans
* Previous solid tumor treated within last 5 years
* Pregnancy
* History of gadolinium contrast allergy
* Non-reversible clotting abnormality
Primary outcome measure(s)
Change in tumor microenvironment during radiotherapy — Prior to radiotherapy, week 2 and week 4 of radiotherapy Repeat biopsy will be analyzed for haematoxylin and eosin (H\&E), pimonidazole (monoclonal IgG1 antibody, Hypoxyprobe MAb1), endogenous proteins associated with hypoxia and/or immune infiltrate, DNA, and RNA.
Change in fMRI during radiotherapy — Prior to radiotherapy, week 2 and week 4 of radiotherapy Assessed through hypoxic regions visible on imaging scans
Trial sites (1)
Facility
City
Region
Status
Princess Margaret Cancer Center
Toronto
Ontario
Recruiting
More University Health Network, Toronto trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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