HN-BIO 02: A Phase II Randomized Study of the Effects of Delayed Elective Radiotherapy on Head and Neck MRI and Immune Response Biomarkers
Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Jun 27, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how radiation therapy affects certain biomarkers (which are indicators of disease) in patients with head and neck squamous cell carcinoma, a type of cancer. The goal is to better understand how these biomarkers change during treatment, which could help improve future therapies. This study is part of a larger research project, and it will take place at one location.
To participate in this study, you must be at least 18 years old and have a confirmed diagnosis of head and neck squamous cell carcinoma that is more than 3 centimeters in size. You should be planning to receive curative surgery or treatment with chemotherapy and/or radiation. Participants will need to undergo MRI scans multiple times and must be able to lie comfortably on their back for about an hour during each scan. The study is not yet recruiting participants, but if you're interested, it’s important to discuss eligibility with your healthcare provider, especially if you have any past medical conditions or allergies that could affect your participation.
Gender
ALL
Eligibility criteria
- 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
About University Health Network, Toronto
University Health Network (UHN), based in Toronto, is a leading academic health sciences center dedicated to advancing patient care through innovative research and education. As a prominent sponsor of clinical trials, UHN integrates cutting-edge scientific discoveries with clinical practice, facilitating the development of new therapies and treatment modalities. With a commitment to improving health outcomes, UHN collaborates with a diverse network of researchers, healthcare professionals, and industry partners, fostering an environment that prioritizes patient safety and ethical standards in clinical research. Through its extensive resources and expertise, UHN plays a pivotal role in transforming healthcare and enhancing the quality of life for patients both locally and globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Toronto, Ontario, Canada
Toronto, , Canada
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported