18F-FMISO PET Guided Dose Escalation in Nasopharyngeal Carcinoma - a Feasibility and Planning Study

The specific aims of this study are:

• To establish hypoxia imaging in NPC patients
• Investigate the dynamics of tumor hypoxia before and during chemoradiation
• Integrate hypoxia imaging into radiation treatment planning protocols
• Design hypoxia adapted radiation schedules
• Identify candidate hypoxia biomarkers

Inclusion criteria

• T3-T4 disease with no evidence of distant metastasis.
• Histological diagnosis of WHO Type II or III NPC
• No evidence of distant metastases in staging work up (including lung, liver and bone imaging).
• Planned for upfront radiotherapy and/or chemotherapy.
• Cross sectional imaging of the primary and neck disease (MRI preferred)
• Performance status of ECOG grade 0 or 1
• No prior tumour therapy
• At least 21 years of age, of either sex.
• Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential;
• Adequate bone marrow, renal and hepatic function defined as follows:

Bone marrow: WBC > 3000 / mm3 (ANC > 1500 / mm3 ) Platelets > 100 000 / mm3. Hb > 10 gm/dl Renal: serum creatinine within institutional normal range(or) lower than the lower limit of institutional normal range : calculated creatinine clearance > 50 ml / min Hepatic: enzymes (SAP, SGOT) < 2x normal: bilirubin < 24 mol / l.

Exclusion criteria

• Allergic to 18F-fluoromisonidazole or Nitroimidazoles
• Planned for neoadjuvant chemotherapy
• Uncontrolled hypercalcaemia: calcium 2.7 mmol/L (10.8 mg/dL).
• Other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
• Have serious active infection.
• Pregnant or lactating female subjects and subjects with reproductive potential not implementing adequate contraceptive measures