Exploring MRI and Biomarkers in Head and Neck Cancer Treatment
HN-BIO: A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers
NA · University Health Network, Toronto · NCT06085781
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06085781 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While the specific combination of fMRI and tumor microenvironment biomarkers in this context is novel, similar studies have shown promise in other cancer types.
Eligibility criteria
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 this trial is running
Toronto, Ontario
- Princess Margaret Cancer Center — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Study coordinator: Andrew McPartlin
- Email: andrew.mcpartlin@uhn.ca
- Phone: 416-946-4501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Squamous Cell Carcinoma of Head and Neck