A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto
About this trial
The purpose of this study is to explore biomarker development in patients with newly diagnosed Head and neck squamous cell carcinoma (HNSCC) receiving curative therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
fMRI
Other interventionFunctional Magnetic Resonance Imaging
Oral Pimonidazole
Other intervention200 mg and 300 mg tablets
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Cohort AOther 2 interventions
Group B: Cohort BOther 2 interventions
Trial outcomes
Primary outcomes
1
Change in tumor microenvironment during radiotherapy
Repeat biopsy will be analyzed for haematoxylin and eosin (H\&E), pimonidazole (monoclonal IgG1 antibody, Hypoxyprobe MAb1), endogenous proteins associated with hypoxia and/or immune infiltrate, DNA, and RNA.
Time frame
Prior to radiotherapy, week 2 and week 4 of radiotherapy2
Change in fMRI during radiotherapy
Assessed through hypoxic regions visible on imaging scans
Time frame
Prior to radiotherapy, week 2 and week 4 of radiotherapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov