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

University Health Network, Toronto

Status: Enrolling

Conditions: Squamous Cell Carcinoma of Head and Neck

Treatments: Other: Oral Pimonidazole; Other: fMRI

Study type: Interventional

Funder types: Other

Identifiers

NCT06085781

HN-BIO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Cohort A

Other group

Description:

Participants who are to receive standard of care radiotherapy will have one biopsy and MRI scan before starting radiotherapy and during week two of radiotherapy. Participants will also have an the option to consent to an additional biopsy and MRI scan during week 4 of radiotherapy. Oral pimonidazole will be taken the night before each biopsy.

Treatment:

Other: fMRI

Other: Oral Pimonidazole

Cohort B

Other group

Description:

Participants who are to receive standard of care curative surgery will have an MRI scan within one week prior to surgery. Tumor tissue from the surgery will also be collected for research. Oral pimonidazole will be taken the night before surgery.

Treatment:

Other: fMRI

Other: Oral Pimonidazole