Back to resultsHN-QUEST: A Study of Head and Neck Imaging Biomarkers (HN-Quest)
Primary Purpose
Head and Neck Squamous Cell Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional other trial for Head and Neck Squamous Cell Carcinoma
Eligibility Criteria
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
Sites / Locations
- Princess Margaret Cancer CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
HNSCC patients
Healthy volunteers and HNSCC patients
Arm Description
Up to 100 HNSCC patients receiving CT-based radiation therapy will receive up to weekly non-contrast MRI scans during treatment.
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.
Outcomes
Primary Outcome Measures
Change in hypoxia level during radiotherapy as assessed by fMRI (functional magnetic resonance imaging)
fMRI images will be used to assess tumour hypoxia status for Head and Neck Squamous Cell Carcinoma (HNSCC)
Change in tumour tissue and microenvironment during radiotherapy as assessed by fMRI
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05919290
First Posted
January 8, 2023
Last Updated
August 18, 2023
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT05919290
Brief Title
HN-QUEST: A Study of Head and Neck Imaging Biomarkers
Acronym
HN-Quest
Official Title
HN QUEST- Evaluation of Online MRgRT and Repeat Functional Imaging in Patients Undergoing Curative (CT)RT for HN Malignancy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2023 (Actual)
Primary Completion Date
July 1, 2026 (Anticipated)
Study Completion Date
July 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
173 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HNSCC patients
Arm Type
Other
Arm Description
Up to 100 HNSCC patients receiving CT-based radiation therapy will receive up to weekly non-contrast MRI scans during treatment.
Arm Title
Healthy volunteers and HNSCC patients
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
Non-invasive imaging technique that is used to take pictures of organs within the body.
Primary Outcome Measure Information:
Title
Change in hypoxia level during radiotherapy as assessed by fMRI (functional magnetic resonance imaging)
Description
fMRI images will be used to assess tumour hypoxia status for Head and Neck Squamous Cell Carcinoma (HNSCC)
Time Frame
Baseline, Week 2 and 4 of radiotherapy, Week 6-8 post radiotherapy
Title
Change in tumour tissue and microenvironment during radiotherapy as assessed by fMRI
Description
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
Time Frame
Weekly MRI imaging during radiotherapy (Up to 7 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rehab Chahin, MD
Phone
416-946-4501
Ext
5062
Email
Rehab.Chahin@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew McPartlin, MD
Organizational Affiliation
Radiation Oncologist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rehab Chahin
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
HN-QUEST: A Study of Head and Neck Imaging Biomarkers
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