NCT05919290 HN-QUEST: A Study of Head and Neck Imaging Biomarkers
| NCT ID | NCT05919290 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Head and Neck Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 173 participants |
| Start Date | 2023-07-26 |
| Primary Completion | 2029-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 173 participants in total. It began in 2023-07-26 with a primary completion date of 2029-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Andrew McPartlin, MD
PRINCIPAL INVESTIGATOR
Radiation Oncologist
Frequently Asked Questions
Who can join the NCT05919290 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05919290 currently recruiting?
Yes, NCT05919290 is actively recruiting participants. Contact the research team at Rehab.Chahin@uhn.ca for enrollment information.
Where is the NCT05919290 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT05919290 clinical trial?
NCT05919290 is sponsored by University Health Network, Toronto. The principal investigator is Andrew McPartlin, MD at Radiation Oncologist. The trial plans to enroll 173 participants.