NCT06085781

A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers

HN-BIO: A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore biomarker development in patients with newly diagnosed Head and neck squamous cell carcinoma (HNSCC) receiving curative therapy.

Detailed description

After being informed about the study and potential risks, all patients giving written informed consent will be assigned to Cohort A or Cohort B. Cohort A will recruit up to 40 patients planned to receive curative radiotherapy for HNSCC. Patients will undergo a baseline fMRI (Functional Magnetic Resonance Imaging) scan and within 72 hours a biopsy of the primary tumor will be performed in out-patient clinic. In week 2 of radiotherapy a further biopsy of the primary site will be performed with a paired fMRI performed within 72 hours prior to biopsy assess evolving changes in imaging and tumor microenvironment biomarkers during radiotherapy. A further optional biopsy and paired MRI scan in week 4 will be considered for patients who are tolerating therapy without toxicities. 16-24 hours prior to each biopsy the volunteer will take oral pimonidazole. Cohort B will recruit up to 20 patients planned to receive curative surgery for HNSCC. Each patient will undergo a baseline fMRI scan performed within one week prior to surgery. At time of initial consent they will receive a prescription for oral pimonidazole hydrochloride which they will be asked to take the 16-24 hours before planned surgery. Following surgery whole tumor samples will be processed to permit spatial reconstruction of pimonidazole staining hypoxia to correlate with fMRI imaging.

Conditions

• Squamous Cell Carcinoma of Head and Neck

Interventions

Type	Name	Description
OTHER	fMRI	Functional Magnetic Resonance Imaging
OTHER	Oral Pimonidazole	200 mg and 300 mg tablets

Timeline

• Start date: 2024-01-29
• Primary completion: 2027-01-15
• Completion: 2027-01-15
• First posted: 2023-10-17
• Last updated: 2026-03-05

Locations

1 site across 1 country: Canada