Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT06085781

Conditions

Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

fMRI

Oral Pimonidazole

Study Details

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.

Conditions

Squamous Cell Carcinoma of Head and Neck

Study ID

NCT06085781

Start date

Jan 29, 2024

Status verified date

Aug, 2026

Completion date

Jan 15, 2027

Anticipated

Primary completion date

Jan 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Cohort A

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.

other: Cohort B

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.

Interventions

fMRI

Functional Magnetic Resonance Imaging

Oral Pimonidazole

200 mg and 300 mg tablets

Primary outcome measure

  • Change in tumor microenvironment during radiotherapy [ Time Frame: Prior to radiotherapy, week 2 and week 4 of radiotherapy ]
  • Change in fMRI during radiotherapy [ Time Frame: Prior to radiotherapy, week 2 and week 4 of radiotherapy ]

Central Contacts and Locations

Central contacts

Andrew McPartlin

416-946-4501andrew.mcpartlin@uhn.ca

Locations

Princess Margaret Cancer Center

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Andrew McPartlin, MD

416-946-2132andrew.mcpartlin@rmp.uhn.ca

Principal Investigator:

Andrew McPartlin

More Information

Sponsor

University Health Network, Toronto

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-08-06.