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

PHASE: II/III

OBJECTIVES:

Primary: To investigate the clinical value of serial quantitative [F-18] FLT positron image assessment of tumor proliferation rates for early assessment of tumor response to radiation or chemoradiotherapy regimens (except with 5-fluorouracil) in comparison to serial quantitative [F-18] FDG images

Secondary: To gain additional clinical information and experience with [F-18]FLT to guide the design of a future, pivotal, Phase III trial where changes in tumor proliferation from pre-treatment baseline values can be used as a early indicator of response to therapy regimens.

DESIGN: Open label, nonrandomized, uncontrolled, single group assignment

DURATION: Pre treatment [F-18] FLT PET scan following a clinical [F-18] FDG PET scan followed by post treatment [F-18] FLT PET scan and a post treatment, clinical [F-18] FDG PET scan at 4 weeks (±1 week) to monitor radiotherapy or chemoradiotherapy.

PROCEDURES: Informed consent, collection of demographic information, medical history, physical examinations, vital signs, 12-lead ECGs, concomitant medication collection, monitor adverse events, pre treatment [F-18] FLT PET scan and post treatment [F-18] FLT PET scan

SUBJECTS: Approximately 60 patients will be enrolled with confirmed lung cancer, or head and neck cancer. The patients must also be starting radiotherapy or a chemoradiotherapy regimen (except with 5-fluorouracil) to be eligible. This allows for approximately 40 evaluable patients to complete this study at approximately four to eight sites and conducted in the United States.

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.