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

Not Applicable

Recruiting

• Conditions: Squamous Cell Carcinoma of Head and Neck

• Registration Number: NCT06085781
• Lead Sponsor: University Health Network, Toronto

Brief 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.

Study Timeline

• Study First Submitted: 2023-10-09
• Study First Submitted QC: 2023-10-09
• Study First Posted: 2023-10-17
• Study Start: 2024-01-29
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07
• Primary Completion: 2027-01-15
• Study Completion: 2027-01-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in tumor microenvironment during radiotherapy	Prior to radiotherapy, week 2 and week 4 of radiotherapy	Repeat biopsy will be analyzed for haematoxylin and eosin (H\&E), pimonidazole (monoclonal IgG1 antibody, Hypoxyprobe MAb1), endogenous proteins associated with hypoxia and/or immune infiltrate, DNA, and RNA.
Change in fMRI during radiotherapy	Prior to radiotherapy, week 2 and week 4 of radiotherapy	Assessed through hypoxic regions visible on imaging scans

Trial Locations

Locations (1)

Princess Margaret Cancer Center; 🇨🇦 Toronto, Ontario, Canada