Status:
RECRUITING
HN-BIO: A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers
Lead Sponsor:
University Health Network, Toronto
Conditions:
Squamous Cell Carcinoma of Head and Neck
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Detailed Description
After being informed about the study and potential risks, all patients giving written informed consent will be assigned to Cohort A or Cohort B. Cohort A will recruit up to 40 patients planned to rec...
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 :
January 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06085781
Start Date
January 29 2024
End Date
January 15 2027
Last Update
September 19 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5G 2M9