A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers

Last updated: March 3, 2026
Sponsor: University Health Network, Toronto
Overall Status: Active - Recruiting

Phase

N/A

Condition

Head And Neck Cancer

Treatment

fMRI

Oral Pimonidazole

Clinical Study ID

NCT06085781
23-5359
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 andable to give written informed consent

  • Adequate renal function: Calculated creatinine clearance >/= 30ml/min

  • Be able to lie comfortably on back for 1 hour

Exclusion

Exclusion Criteria:

  • As judged by investigator evidence of systemic disease that makes unsuitable forstudy

  • 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

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: fMRI
Phase:
Study Start date:
January 29, 2024
Estimated Completion Date:
January 15, 2027

Study 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.

Connect with a study center

  • Princess Margaret Cancer Center

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Center

    Toronto 6167865, Ontario 6093943 M5G 2M9
    Canada

    Site Not Available

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