Skip to content

Evaluation of hypoxia using genetic and imaging biomarker in head and neck squamous cell carcinoma

Biomarkers of hypoxia evaluation with molecular and 64copper (II) diacetylbis (N4)methylthiosemicarbazone (CuATSM) positron emission tomography/computed tomography (PET/CT) imaging techniques in head and neck squamous cell carcinomas (BoHEMIaN study)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN49555010
Enrollment
40
Registered
2012-10-11
Start date
2012-10-14
Completion date
Unknown
Last updated
2017-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and neck cancer Cancer

Interventions

Tissue samples will be obtained from the Head and Neck Tissue and Data Bank. Immunohistochemistry, expression profiling and miRNA screening to investigate markers of hypoxia will be performed. Copper-

Sponsors

Guy's and St Thomas' NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with stage III-IV histologically proven HPV negative oropharyngeal squamous cell carcinoma to be treated with radical concomitant chemotherapy and radiotherapy 2. Patients have consented to their original biospy being stored in the tissue bank at GSTFT 3. Age > 18 years 4. ECOG Performance Status 12 weeks 6. Adequate organ function and absence of other major concomitant illness, allowing the patient to tolerate the delivery of the radiotracer 7. Patients must be able to provide written and voluntary informed consent 8. All women of childbearing age must have a negative serum or urine pregnancy test documented within 72 hours prior to study enrollment 9. Male and female participants

Exclusion criteria

Exclusion criteria: 1. Patients with impaired renal function (serum creatinine > 200) 2. Patients with severely impaired liver function 3. Serious intercurrent conditions or other nonmalignant illnesses that are uncontrolled or whose control may be affected by participation in this study 4. Any patient who has urinary or faecal incontinence 5. Previous history of cancer other than skin basal cell carcinoma 6. ECOG Performance Status >/= 3 7. Pregnant or breastfeeding women

Design outcomes

Primary

MeasureTime frame
Characterisation and correlation of molecular and imaging biomarkers of hypoxia

Secondary

MeasureTime frame
No secondary outcome measures

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026