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NCT Number: NCT05919290

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 1X6, Canada

Location status: Recruiting

Location contact

Rehab Chahin

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Other

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

Primary outcomes

  1. 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)

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Rehab Chahin, MD

CONTACT

[email protected]

416-946-4501 ext. 5062

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Acronym: HN-Quest

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Jun 26, 2023
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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