Recruiting

Imaging Biomarkers

Sponsor:

University Health Network, Toronto

Code:

NCT05919290

Conditions

Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

MRI

Study Details

Brief summary:

This is a multi arm, single center, investigator initiated study to investigate online adaptive radiotherapy and biomarker development in patients with newly diagnosed HNSCC (Head and Neck Squamous Cell Carcinoma) receiving curative therapy.

The study will consist of two prospective arms. In Arm 1 up to 100 HNSCC patients receiving (CT)RT (computed tomography-based radiation therapy) will receive up to weekly non-contrast MRI (magnetic resonance imaging) scans during treatment. Arm 2 consists of two cohorts. In cohort A up to 20 healthy volunteers will undergo non-contrast MRI at two time points. In cohort B up to 53 patients planned to receive curative (chemo) radiotherapy for HNSCC will undergo two baseline MRI scans, one MRI in week 2 and week 4, and final MRI scan 6-8 weeks after completion of treatment.

Conditions

Head and Neck Squamous Cell Carcinoma

Study ID

NCT05919290

Start date

Jul 26, 2023

Status verified date

Mar, 2026

Completion date

Jul 1, 2029

Anticipated

Primary completion date

Jul 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria for Cancer Patients:

  • 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
  • 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 for Cancer Patients:

  • 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 significant obstructive airway disease
  • History of gadolinium contrast allergy

Inclusion Criteria for Healthy Volunteers

  • Age >/= 18 years
  • Able to receive and understand verbal and written information regarding study and able to give written informed consent
  • Willingness to undergo repeat MRI

Exclusion Criteria for Healthy Volunteers

  • Unwillingness to sign informed consent
  • Contra-indication for MRI
  • Underlying significant respiratory disease

Study Design

Enrollment

173 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: HNSCC patients

Up to 100 HNSCC patients receiving CT-based radiation therapy will receive up to weekly non-contrast MRI scans during treatment.

other: Healthy volunteers and HNSCC patients

Cohort A - Up to 20 healthy volunteers will undergo non-contrast MRI at two time points.

Cohort B - Up to 53 patients planned to receive curative (chemo) radiotherapy for HNSCC will undergo two baseline MRI scans, one MRI in week 2 and week 4, and final MRI scan 6-8 weeks after completion of treatment.

Interventions

MRI

Non-invasive imaging technique that is used to take pictures of organs within the body.

Primary outcome measure

  • Change in hypoxia level during radiotherapy as assessed by fMRI (functional magnetic resonance imaging) [ Time Frame: Baseline, Week 2 and 4 of radiotherapy, Week 6-8 post radiotherapy ]
  • Change in tumour tissue and microenvironment during radiotherapy as assessed by fMRI [ Time Frame: Weekly MRI imaging during radiotherapy (Up to 7 weeks) ]

Central Contacts and Locations

Central contacts

Rehab Chahin, MD

416-946-4501Rehab.Chahin@uhn.ca

Locations

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 1X6

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-03-05.