Exploring MRI and Biomarkers in Head and Neck Cancer Treatment
Official title: HN-BIO: A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers
Run by University Health Network, Toronto · NCT06085781 · Data updated 2026-11-12
This study is testing how MRI scans and certain biological markers can help doctors understand how well treatments are working for people with newly diagnosed head and neck cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | January 29, 2024 |
| Main results expected | January 15, 2027 |
| Study ends | January 15, 2027 |
| Registry record updated | August 6, 2026 |
| Trial ID | NCT06085781 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with histologically confirmed head and neck squamous cell carcinoma planned for curative surgery or radiotherapy.
✕Probably not a fit
Patients with systemic diseases, contraindications for MRI, or those who have had previous solid tumors treated within the last five years may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the development of biomarkers in patients with newly diagnosed head and neck squamous cell carcinoma (HNSCC) undergoing curative therapy. Patients will be divided into two cohorts: one receiving radiotherapy and the other undergoing surgery. Each cohort will undergo functional MRI scans and biopsies at various stages of treatment to assess changes in tumor microenvironment and imaging biomarkers. The study aims to correlate these findings with treatment responses and improve understanding of tumor behavior during therapy.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies and personalized therapies for patients with head and neck cancer.
How similar studies have gone: While the specific combination of fMRI and tumor microenvironment biomarkers in this context is novel, similar studies have shown promise in other cancer types.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Princess Margaret Cancer Center
Toronto, Ontario, Canada Recruiting
Study contacts
- Study coordinator: Andrew McPartlin
- Email: andrew.mcpartlin@uhn.ca
- Phone: 416-946-4501
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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TMV vaccine alone or with toripalimab for recurrent head and neck cancer
This study tests a personalized TMV vaccine, alone and with toripalimab, in adults whose head and neck cancer has returned and is planning salvage surgery.
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Iparomlimab plus tuvonralimab, with or without chemotherapy, for second-line and later recurrent or metastatic head and neck squamous cell carcinoma
This will try whether combining two antibodies, iparomlimab and tuvonralimab, with or without chemotherapy helps people with recurrent or metastatic head and neck squamous cell carcinoma whose cancer progressed after at least one systemic treatment.
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Cetuximab with PD-1 therapy plus chemotherapy vs PD-1 therapy with chemotherapy for recurrent/metastatic head and neck cancer
This trial tests whether adding cetuximab to a PD-1 inhibitor plus chemotherapy helps people with recurrent or metastatic head and neck squamous cell cancer who aren’t candidates for curative treatment.
-
Neoadjuvant CADI-05 with pembrolizumab for resectable locally advanced head and neck squamous cell carcinoma
This will test whether adding weekly CADI-05 skin injections to pembrolizumab before surgery helps adults with resectable locally advanced head and neck squamous cell cancer.
-
5-Fluorouracil Response and Optimization (FROST)
This trial will test two different dosing schedules of 5‑fluorouracil as second-line-or-later treatment for people with recurrent or metastatic head and neck squamous cell carcinoma who have already had platinum and PD‑1 inhibitor therapy.
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Amivantamab added to pembrolizumab and platinum chemotherapy versus pembrolizumab with platinum/5‑FU for recurrent/metastatic head and neck squamous cell carcinoma
This trial will see if adding amivantamab to pembrolizumab and platinum‑based chemotherapy helps adults with recurrent or metastatic head and neck squamous cell carcinoma who have not yet had systemic treatment in the metastatic setting.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.