Positron Emission Tomography Imaging With [F-18] FLT Compared to [F-18] FDG in Cancer Patients for Treatment Evaluation

Inclusion Criteria

• •1. Patient provides written Informed Consent and is willing to comply with protocol requirements
• •2. Patient is at least 18 years of age on the day of dosing (male or female of any race or ethnicity)
• •3. Patient is capable of lying still in the PET scanner for the protocol required time frame(s)
• •4. Patient has a diagnosis of one of the following malignancies (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)
• •5. 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
• •6. Patient is scheduled to start radiotherapy or a chemoradiotherapy regimen for curative intent
• •7. 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)
• •8. 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
• •9. Patient has not received or intends to receive 5-fluorouracil (5-FU-chemotherapeutic agent)
• •10. Patient has a score of greater than or equal to (≥) 60% on the Karnofsky Performance Status Scale
• •1. Patient is a pregnant or lactating female. These methods will be used to 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.
• •2. Patient is undergoing treatment with palliative intent
• •3. Patient has received an investigational compound and/or medical device within 14 days before admission into this study
• •4. 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
• •5. Patient is determined by the Investigator that he/she is clinically unsuitable for the study.