a multi - center study of pet imaging with [f-18] flt & [f-18] fdg in cancer patients for treatment evaluation

Conditions: Lung Cancer; Head and Neck Cancer

Summary: approximately 60 patients will be enrolled with highly suspected lung cancer, or head and neck cancer. the patients must also be starting radiotherapy or a chemoradiotherapy regimen (except with 5-fluorouracil). the patients will undergo 3 visits. one screening, one pre therapy pet/ct imaging visit, and one (3-5 weeks after the start of therapy) post pet/ct imaging visit. this study will evaluate the flt and fdg images for tumor proliferation rates for early assessment of tumor response to radiation or chemo-radiation combo.

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.

Eligibility criteria:
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.

Keywords: lung cancer head and neck cancer radiotherapy chemoradiotherapy radiation chemoradiation flt [f-18]flt fdg [f-18]fdg