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

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

NCT ID: NCT05919290

Condition: Head and Neck Squamous Cell Carcinoma

Conditions: Official terms:
Squamous Cell Carcinoma of Head and Neck

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Other

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: MRI
Description: Non-invasive imaging technique that is used to take pictures of organs within the body.
Arm group label: HNSCC patients
Arm group label: Healthy volunteers and HNSCC patients

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Princess Margaret Cancer Centre

Address:
City: Toronto
Zip: M5G 1X6
Country: Canada

Status: Recruiting

Contact:
Last name: Rehab Chahin

Start date: July 26, 2023

Completion date: July 1, 2026

Lead sponsor:
Agency: University Health Network, Toronto
Agency class: Other

Source: University Health Network, Toronto

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05919290