Clinical trial · Interventional
A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers
HN-BIO: A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers
NCT06085781CI-TRIAL-00120802HN-BIOrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Carcinoma of Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fMRI | Other | — | UNRESOLVED |
| Oral Pimonidazole | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Cohort A
- description
- 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.
- interventionNames
- Other: fMRI
- Other: Oral Pimonidazole
- type
- OTHER
- label
- Cohort B
- description
- 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.
- interventionNames
- Other: fMRI
- Other: Oral Pimonidazole
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.