HN-QUEST: A Study of Head and Neck Imaging Biomarkers (HN-Quest)

March 3, 2026 updated by: University Health Network, Toronto

HN QUEST- Evaluation of Online MRgRT and Repeat Functional Imaging in Patients Undergoing Curative (CT)RT for HN Malignancy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to develop and investigate novel and established MR (magnetic resonance) imaging sequences as predictive and prognostic radiotherapy biomarkers. Radiotherapy is a fundamental treatment modality for Head and Neck Squamous Cell Carcinoma (HNSCC) with a majority of patients receiving radiation as part of their care pathway. Although treatment is effective, there remains a risk of failure particularly in those presenting with locally advanced disease. In addition, significant proportion of patients receiving radiotherapy will suffer long-term side effects related to their treatment. The addition of concurrent chemotherapy improves the efficacy of radiotherapy, but at the cost of increased treatment related toxicity. The treatment related toxicity and risk of treatment failure means there is a compelling clinical need to personalize therapy based on a patient's early response to radiotherapy.

Study Type

Interventional

Enrollment (Estimated)

173

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X6
        • Recruiting
        • Princess Margaret Cancer Centre
        • Contact:
          • Rehab Chahin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: MRI
Non-invasive imaging technique that is used to take pictures of organs within the body.
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.
Other: MRI
Non-invasive imaging technique that is used to take pictures of organs within the body.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in tumour tissue and microenvironment during radiotherapy as assessed by fMRI
Time Frame: Weekly MRI imaging during radiotherapy (Up to 7 weeks)
fMRI images will be used to evaluate on treatment tumour response to determine the effect of dose escalation to tumor sub regions using a daily online adaptive radiation treatment approach
Weekly MRI imaging during radiotherapy (Up to 7 weeks)
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
fMRI images will be used to assess tumour hypoxia status for Head and Neck Squamous Cell Carcinoma (HNSCC)
Baseline, Week 2 and 4 of radiotherapy, Week 6-8 post radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Andrew McPartlin, MD, Radiation Oncologist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2023

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

January 8, 2023

First Submitted That Met QC Criteria

June 21, 2023

First Posted (Actual)

June 26, 2023

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-5864

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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