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MRI Biomarkers for Head and Neck Cancer (HN-Quest Trial)

N/A

Recruiting

Led By Andrew McPartlin, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Primary or nodal disease > 3cm for biomarker imaging

Age >/= 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 2 and 4 of radiotherapy, week 6-8 post radiotherapy

Awards & highlights

HN-Quest Trial Summary

This trial will assess the safety and feasibility of online adaptive radiotherapy for HNSCC, as well as identify biomarkers for treatment response.

Who is the study for?

This trial is for adults over 18 with Head and Neck Squamous Cell Carcinoma (HNSCC), specifically those with tumors larger than 3cm, who are fit enough for curative surgery or therapy. Participants must understand the study details, consent in writing, have good kidney function, be able to lie on their back for an hour, and agree to multiple MRIs.Check my eligibility

What is being tested?

The HN-QUEST study is testing how well MRI scans work as biomarkers in tracking treatment progress of HNSCC. It has two arms: one where patients get weekly MRIs during CT-based radiation therapy; another split into healthy volunteers getting two MRIs and patients receiving several MRIs before, during, and after chemo/radiotherapy.See study design

What are the potential side effects?

Since the intervention being studied is non-contrast MRI scanning which does not involve radiation or medication typically associated with side effects like drugs do. However lying still might cause discomfort.

HN-Quest Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer or its spread is larger than 3cm.

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I am 18 years old or older.

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My kidneys work well enough (creatinine clearance is 30ml/min or more).

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I can lie on my back comfortably for an hour.

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I have been diagnosed with squamous cell carcinoma in the head or neck area.

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I can take care of myself and perform daily activities.

HN-Quest Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 2 and 4 of radiotherapy, week 6-8 post radiotherapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 2 and 4 of radiotherapy, week 6-8 post radiotherapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 2 and 4 of radiotherapy, week 6-8 post radiotherapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in hypoxia level during radiotherapy as assessed by fMRI (functional magnetic resonance imaging)

Change in tumour tissue and microenvironment during radiotherapy as assessed by fMRI

HN-Quest Trial Design

2Treatment groups

Experimental Treatment

Group I: Healthy volunteers and HNSCC patientsExperimental Treatment1 Intervention

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.

Group II: HNSCC patientsExperimental Treatment1 Intervention

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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,476 Previous Clinical Trials

485,007 Total Patients Enrolled

Andrew McPartlin, MDPrincipal InvestigatorRadiation Oncologist

1 Previous Clinical Trials

45 Total Patients Enrolled

Media Library

HNSCC patients Clinical Trial Eligibility Overview. Trial Name: NCT05919290 — N/A

Head and Neck Squamous Cell Carcinoma Research Study Groups: HNSCC patients, Healthy volunteers and HNSCC patients

Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: HNSCC patients Highlights & Side Effects. Trial Name: NCT05919290 — N/A

HNSCC patients 2023 Treatment Timeline for Medical Study. Trial Name: NCT05919290 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies for individuals to participate in this trial?

"Affirmative, an examination of clinicaltrials.gov reveals that this trial is enrolling patients. It was initially posted on July 26th 2023 and its most recent update occurred on August 18th 2023. 173 participants need to be sourced from 1 centre in particular."

Answered by AI

What is the uppermost amount of participants included in this clinical experiment?

"Affirmative. According to the clinicaltrials.gov profile, this study is currently enrolling 173 participants at a single site upon its inception on July 26th 2023 and most recently updated on August 18th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "HN-QUEST: A Study of Head and Neck Imaging Biomarkers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05919290.