NCT06487403Recruiting
HN-BIO 02: A Phase II Randomized Study of the Effects of Delayed Elective Radiotherapy on Head and Neck MRI and Immune Response Biomarkers
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 27 Jun 2024
- Start date
- 17 Apr 2025
- Primary completion date
- 1 Aug 2028
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Head and neck cancer
- NCT number
- NCT06487403
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 17 Apr 2025 to the primary completion date, 1 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently participating in another study that requires standard of care radiotherapy
- Previous solid tumor treated within last 5 years that investigator feels makes unsuitable for study
Other illness
- As judged by investigator evidence of systemic disease that makes unsuitable for study
- History of gadolinium contrast allergy
- History of significant respiratory disease
Other
- More than one contralateral nodal level requiring treatment in phase I
- As judged by investigator, it is deemed unsafe or medically inadvisable to conduct repeat biopsies
- Contra-indication for serial MRI scans
- Pregnancy
- Non-reversible clotting abnormality
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.