A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers (HN-BIO)
HN-BIO: A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Andrew McPartlin
- Phone Number: 4855 416-946-4501
- Email: andrew.mcpartlin@uhn.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2M9
- Recruiting
- Princess Margaret Cancer Center
-
Contact:
- Andrew McPartlin, MD
- Phone Number: 416-946-2132
- Email: andrew.mcpartlin@rmp.uhn.ca
-
Principal Investigator:
- Andrew McPartlin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Cohort A
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.
|
Functional Magnetic Resonance Imaging
200 mg and 300 mg tablets
|
|
Other: Cohort B
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.
|
Functional Magnetic Resonance Imaging
200 mg and 300 mg tablets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Prior to radiotherapy, week 2 and week 4 of radiotherapy
|
|
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
|
Prior to radiotherapy, week 2 and week 4 of radiotherapy
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-5359
- MCPARTLIN-01 (Registry Identifier: Health Canada)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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