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Trial Title:
HN-BIO: A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers
NCT ID:
NCT06085781
Condition:
Squamous Cell Carcinoma of Head and Neck
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:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
fMRI
Description:
Functional Magnetic Resonance Imaging
Arm group label:
Cohort A
Arm group label:
Cohort B
Intervention type:
Other
Intervention name:
Oral Pimonidazole
Description:
200 mg and 300 mg tablets
Arm group label:
Cohort A
Arm group label:
Cohort B
Summary:
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.
Detailed description:
After being informed about the study and potential risks, all patients giving written
informed consent will be assigned to Cohort A or Cohort B.
Cohort A will recruit up to 40 patients planned to receive curative radiotherapy for
HNSCC. Patients will undergo a baseline fMRI (Functional Magnetic Resonance Imaging) scan
and within 72 hours a biopsy of the primary tumor will be performed in out-patient
clinic. In week 2 of radiotherapy a further biopsy of the primary site will be performed
with a paired fMRI performed within 72 hours prior to biopsy assess evolving changes in
imaging and tumor microenvironment biomarkers during radiotherapy. A further optional
biopsy and paired MRI scan in week 4 will be considered for patients who are tolerating
therapy without toxicities. 16-24 hours prior to each biopsy the volunteer will take oral
pimonidazole.
Cohort B will recruit up to 20 patients planned to receive curative surgery for HNSCC.
Each patient will undergo a baseline fMRI scan performed within one week prior to
surgery. At time of initial consent they will receive a prescription for oral
pimonidazole hydrochloride which they will be asked to take the 16-24 hours before
planned surgery. Following surgery whole tumor samples will be processed to permit
spatial reconstruction of pimonidazole staining hypoxia to correlate with fMRI imaging.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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 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 >/= 30ml/min
- Be able to lie comfortably on back for 1 hour
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Princess Margaret Cancer Center
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Andrew McPartlin, MD
Phone:
416-946-2132
Email:
andrew.mcpartlin@rmp.uhn.ca
Start date:
January 29, 2024
Completion date:
January 15, 2027
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/NCT06085781
