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

Not Applicable
Completed
Conditions
Head and neck cancer
Cancer
Registration Number
ISRCTN49555010
Lead Sponsor
Guy's and St Thomas' NHS Foundation Trust (UK)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
40
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 5. Life expectancy > 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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Characterisation and correlation of molecular and imaging biomarkers of hypoxia
Secondary Outcome Measures
NameTimeMethod
o secondary outcome measures
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