Status:
RECRUITING
HN-BIO 02: A Phase II Randomized Study of the Effects of Delayed Elective Radiotherapy on Head and Neck MRI and Immune Response Biomarkers
Lead Sponsor:
University Health Network, Toronto
Conditions:
Squamous Cell Carcinoma of Head and Neck
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a single centre prospective exploratory study of effects of radiation therapy on biomarker development in patients with newly diagnosed (head and neck squamous cell carcinoma) HNSCC receiving ...
Detailed Description
This study will recruit up to 40 patients planned to receive curative (chemo) radiotherapy for (head and neck squamous cell carcinoma) HNSCC with primary tumor and/or involved lymph node suitable for ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06487403
Start Date
April 17 2025
End Date
August 1 2028
Last Update
September 16 2025
Active Locations (1)
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1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9