Head and Neck Squamous Cell Carcinoma
Conditions
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 (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.
Detailed description
The purpose of this study is to develop and investigate novel and established MR (magnetic resonance) 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.
Interventions
OTHERMRI
Non-invasive imaging technique that is used to take pictures of organs within the body.
Sponsors
University Health Network, Toronto
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for Cancer Patients: * 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 * 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
for Cancer Patients: * 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 significant obstructive airway disease * History of gadolinium contrast allergy Inclusion Criteria for Healthy Volunteers * Age \>/= 18 years * Able to receive and understand verbal and written information regarding study and able to give written informed consent * Willingness to undergo repeat MRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hypoxia level during radiotherapy as assessed by fMRI (functional magnetic resonance imaging) | 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 |
Countries
Canada
Contacts
CONTACTRehab Chahin, MD
PRINCIPAL_INVESTIGATORAndrew McPartlin, MD
Radiation Oncologist
Outcome results
None listed