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Testing MRI for head and neck squamous cell carcinoma

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

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

Condition: Head and Neck Squamous Cell CarcinomaSponsor: University Health Network, TorontoTarget enrollment: 173
  • 2 groups
  • One site, in Toronto
  • Recruiting
Princess Margaret Cancer Centre, Toronto, Ontario

Interventions

  • Other intervention

    MRI

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

Canadian Sites (1)

1 of 1 recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario

    Recruiting

Eligibility Criteria

See who this study is looking for38 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • +History of gadolinium contrast allergy
  • +for Cancer Patients:
  • +Age \>/= 18 years
  • +Histologically proven Head and Neck Squamous Cell carcinoma
  • +Primary or nodal disease \> 3cm for biomarkerBiomarkerSomething measurable in the body used as a signal of what is happening.Read more → imaging
  • +Willingness to undergo repeat MRI
  • +Able to receive and understand verbal and written information regarding study and able to give written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
  • +Adequate renal function: Calculated creatinine clearance \>/= 30ml/min
  • +Be able to lie comfortably on back for 1 hour
  • +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → for Cancer Patients:
  • +As judged by investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → evidence of systemic disease that makes unsuitable for study
  • +Contra-indication for serial MRI scans
  • +Previous solid tumor treated within last 5 years
  • +History of significant obstructive airway disease
  • +Inclusion CriteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → for Healthy VolunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →
  • +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
  • +Planned for curative surgery or (chemo)radiotherapy

Exclusion

  • History of gadolinium contrast allergy
  • for Cancer Patients:
  • As judged by investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → evidence of systemic disease that makes unsuitable for study
  • Contra-indication for serial MRI scans
  • Previous solid tumor treated within last 5 years
  • History of significant obstructive airway disease
  • Inclusion CriteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → for Healthy VolunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →
  • Age \>/= 18 years
  • Able to receive and understand verbal and written information regarding study and able to give written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
  • Willingness to undergo repeat MRI
  • Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → for Healthy Volunteers
  • Unwillingness to sign informed consent
  • Contra-indication for MRI
  • Underlying significant respiratory disease
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study does not fall into the standard research categories.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 2 groups in this study.

Groups A and B receive MRI.

Registry label: A: HNSCC patients · B: Healthy volunteers and HNSCC patients

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Groups are assigned by the study team using set rules, rather than by chance.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 173 people.

The study is currently expected to finish around July 2029.

The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, Week 2 and 4 of radiotherapy, Week 6-8 post radiotherapy.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Change in hypoxia level during radiotherapy as assessed by fMRI (functional magnetic resonance imaging) — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, Week 2 and 4 of radiotherapy, Week 6-8 post radiotherapy.

Change in tumour tissue and microenvironment during radiotherapy as assessed by fMRI — measured over Weekly MRI imaging during radiotherapy (Up to 7 weeks).

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT05919290 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About MRIOther

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

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

Groups are assigned by the study team using set rules, rather than by chance.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 18 years, with no upper limit given.

It is open to people of any sex.

It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, Week 2 and 4 of radiotherapy, Week 6-8 post radiotherapy.

The study as a whole is currently expected to finish around 2029-07-01.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 173 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Toronto, Ontario, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

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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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.