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NCT06487403
HN-BIO 02: A Phase II Randomized Study of the Effects of Delayed Elective Radiotherapy on Head and Neck MRI and Immune Response Biomarkers
Conditions: Squamous Cell Carcinoma of Head and Neck
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: University Health Network, Toronto
Location: Princess Margaret Cancer Centre Toronto Ontario
Summary
This is a single centre prospective exploratory study of effects of delayed radiation therapy on adaptive immune response in patients with newly diagnosed (head and neck squamous cell carcinoma) HNSCC receiving curative radiotherapy. This research is part 2 of the HN-BIO study.
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
Source: ClinicalTrials.gov (NCT06487403). StuddyBuddy aggregates publicly available trial information.