HN-BIO: A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers

• Sponsor: University Health Network, Toronto (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06085781
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 48
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Squamous Cell Carcinoma of Head and Neck	Other: fMRI; Other: Oral Pimonidazole	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: HN-BIO: A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers
• Anticipated Study Start Date: Dec 15, 2023
• Anticipated Primary Completion Date: Dec 15, 2027
• Anticipated Study Completion Date: Dec 15, 2027

Arms and Interventions

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.	Other: fMRI; Functional Magnetic Resonance Imaging; Other: Oral Pimonidazole; 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.	Other: fMRI; Functional Magnetic Resonance Imaging; Other: Oral Pimonidazole; 200 mg and 300 mg tablets

Outcome Measures

Primary Outcome Measures

1. Change in tumor microenvironment during radiotherapy [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.

2. Change in fMRI during radiotherapy [Prior to radiotherapy, week 2 and week 4 of radiotherapy]

   Assessed through hypoxic regions visible on imaging scans

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Princess Margaret Cancer Center	Toronto	Ontario	Canada	M5G 2M9

Sponsors and Collaborators

• University Health Network, Toronto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Health Network, Toronto
• ClinicalTrials.gov Identifier: NCT06085781
• Other Study ID Numbers: HN-BIO
• First Posted: Oct 17, 2023
• Last Update Posted: Oct 17, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Squamous Cell Carcinoma of Head and Neck

Study Results

No Results Posted as of Oct 17, 2023