Squamous Cell Carcinoma of Head and NeckHN-BIONCT06085781
A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers
A study testing fMRI and Oral Pimonidazole in people with Squamous Cell Carcinoma of Head and Neck, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- fMRI and Oral Pimonidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jan 2024to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Center
Toronto, Ontario, M5G 2M9
Andrew McPartlin, MD, 416-946-2132, andrew.mcpartlin@rmp.uhn.ca
Andrew McPartlin
About this study
Official title: HN-BIO: A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers
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.
Read the 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.
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Being tested
- fMRI, Oral Pimonidazole
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIOther
Functional Magnetic Resonance Imaging
Oral PimonidazoleOther
200 mg and 300 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Other | Participants who are to receive standard of care radiotherapy will have one biopsy and MRI scan before starting radiotherapy and during week two of radiotherapy. Participants will also have an the option to consent to an additional biopsy and MRI scan during week 4 of radiotherapy. Oral pimonidazole will be taken the night before each biopsy. Receives: Other: fMRI; Other: Oral Pimonidazole |
| Cohort B | Other | Participants who are to receive standard of care curative surgery will have an MRI scan within one week prior to surgery. Tumor tissue from the surgery will also be collected for research. Oral pimonidazole will be taken the night before surgery. Receives: Other: fMRI; Other: Oral Pimonidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Prior to radiotherapy, week 2 and week 4 of radiotherapy
Change in fMRI during radiotherapy
Assessed through hypoxic regions visible on imaging scans
Measured: Prior to radiotherapy, week 2 and week 4 of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start29 Jan 2024
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085781
- Sponsor's protocol ID
- 23-5359
- Other IDs
- MCPARTLIN-01
- Acronym
- HN-BIO
- Status last verified
- Aug 2026
- First submitted
- 9 Oct 2023
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HN-BIO: A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers
- ClinicalTrials.gov ID
- NCT06085781
- Acronym / sponsor ID
- HN-BIO / 23-5359
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Other | Other: fMRI, Other: Oral PimonidazoleParticipants who are to receive standard of care radiotherapy will have one biopsy and MRI scan before starting radiotherapy and during week two of radiotherapy. Participants will also have an the option to consent to an additional biopsy and MRI scan during week 4 of radiotherapy. Oral pimonidazole will be taken the night before each biopsy. |
| Cohort B | Other | Other: fMRI, Other: Oral PimonidazoleParticipants who are to receive standard of care curative surgery will have an MRI scan within one week prior to surgery. Tumor tissue from the surgery will also be collected for research. Oral pimonidazole will be taken the night before surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRIFunctional Magnetic Resonance Imaging | Other | Cohort A, Cohort B |
| Oral Pimonidazole200 mg and 300 mg tablets | Other | Cohort A, Cohort B |
Primary outcome
Change in tumor microenvironment during radiotherapy
Time frame: Prior to radiotherapy, week 2 and week 4 of 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.
Change in fMRI during radiotherapy
Time frame: Prior to radiotherapy, week 2 and week 4 of radiotherapy
Assessed through hypoxic regions visible on imaging scans
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI and Oral Pimonidazole in people with Squamous Cell Carcinoma of Head and Neck, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew McPartlin (416-946-4501 ext. 4855, andrew.mcpartlin@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in tumor microenvironment during radiotherapy (time frame: Prior to radiotherapy, week 2 and week 4 of radiotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.