A Multi - Center Study Of PET Imaging With [F-18] FLT & [F-18] FDG in Cancer Patients for Treatment Evaluation

Inclusion Criteria

• Patient provides written Informed Consent and is willing to comply with protocol requirements
• Patient is at least 18 years of age on the day of dosing (male or female of any race or ethnicity)
• Patient is capable of lying still in the PET scanner for the protocol required time frame(s)
• Patient has a diagnosis of one of the following malignancies using the TNM Staging System:
• Lung cancer (T3 grade up, node positive, but no metastatic disease)
• Head and neck cancer (T3 grade up, node positive, but no metastatic disease)
• Patient has undergone a comparative, diagnostic procedure with lesion(s) visible, other than ultrasound, that includes, but is not limited to computed tomography (CT), magnetic resonance imaging (MRI), nuclear medicine imaging, endoscopy, laparoscopy, standard abdominal x-ray, biopsy and/or surgery for one of the above mentioned areas
• Patient is scheduled to start radiotherapy or a chemoradiotherapy regimen for curative intent
• As a part of his/her standard radiotherapy or chemoradiotherapy regimen, patient is scheduled to have clinical [F-18]FDG PET scans pre treatment and post treatment (at about 4 weeks (±1 week) after the start of therapy)
• Patient is scheduled to have the investigational, pre treatment [F-18] FLT PET scan recommended to be within ± 2 days of the clinical, pre treatment [F-18] FDG PET scan
• Patient has not received or intends to receive 5-fluorouracil (chemotherapeutic agent)
• Patient has a score of greater than or equal to (>/=) 60% on the Karnofsky Performance Status Scale

Exclusion Criteria

• Patient is a pregnant or lactating female. Exclude the possibility of pregnancy:
• by testing on site at the institution (serum or urine βHCG) within 48 hours prior to the start of each investigational product administration
• by surgical history (eg, tubal ligation or hysterectomy)
• by patient's history of being post menopausal with a minimum 1 year without menses
• Patient is undergoing treatment with palliative intent
• Patient has received an investigational compound and/or medical device within 14 days before admission into this study
• Patient has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations
• Patient is determined by the Investigator that he/she is clinically unsuitable for the study.