Clinical trial NCT06085781: HN-BIO: A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers
Official title: HN-BIO: A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Squamous Cell Carcinoma of Head and Neck
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in tumor microenvironment during radiotherapy
timeFrame: Prior to radiotherapy, week 2 and week 4 of radiotherapy
measure: Change in fMRI during radiotherapy
timeFrame: Prior to radiotherapy, week 2 and week 4 of radiotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
state: Ontario
Study officials:
References: