Head and Neck Squamous Cell Carcinoma Clinical Trial
— HN-QuestOfficial title:
HN QUEST- Evaluation of Online MRgRT and Repeat Functional Imaging in Patients Undergoing Curative (CT)RT for HN Malignancy
NCT number | NCT05919290 |
Other study ID # | 22-5864 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 26, 2023 |
Est. completion date | July 1, 2026 |
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.
Status | Recruiting |
Enrollment | 173 |
Est. completion date | July 1, 2026 |
Est. primary completion date | July 1, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 Exclusion Criteria for Healthy Volunteers - Unwillingness to sign informed consent - Contra-indication for MRI - Underlying significant respiratory disease |
Country | Name | City | State |
---|---|---|---|
Canada | Princess Margaret Cancer Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in hypoxia level during radiotherapy as assessed by fMRI (functional magnetic resonance imaging) | fMRI images will be used to assess tumour hypoxia status for Head and Neck Squamous Cell Carcinoma (HNSCC) | Baseline, Week 2 and 4 of radiotherapy, Week 6-8 post radiotherapy | |
Primary | Change in tumour tissue and microenvironment during radiotherapy as assessed by fMRI | 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 | Weekly MRI imaging during radiotherapy (Up to 7 weeks) |
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