Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06487403

HN-BIO 02: A Phase II Randomized Study of the Effects of Delayed Elective Radiotherapy on Head and Neck MRI and Immune Response Biomarkers

Led by University Health Network, Toronto · Updated on 2026-03-04

40

Participants Needed

1

Research Sites

171 weeks

Total Duration

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AI-Summary

What this Trial Is About

This is a single centre prospective exploratory study of effects of radiation therapy on biomarker development in patients with newly diagnosed (head and neck squamous cell carcinoma) HNSCC receiving curative therapy. This research is part 2 of the HN-BIO study.

CONDITIONS

Official Title

HN-BIO 02: A Phase II Randomized Study of the Effects of Delayed Elective Radiotherapy on Head and Neck MRI and Immune Response Biomarkers

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age �3e= 18 years
  • Histologically proven Head and Neck Squamous Cell carcinoma
  • Primary or nodal disease �3e 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 imaging
  • Able to receive and understand verbal and written information regarding study and able to -give written informed consent
  • Adequate renal function: Calculated creatinine clearance �3e= 30ml/min
  • Be able to lie comfortably on back for 1 hour
Not Eligible

You will not qualify if you...

  • 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 gadolinium contrast allergy
  • Non-reversible clotting abnormality

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

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Research Team

A

Andrew McPartlin, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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