Lung Cancer Clinical Trial
Official title:
A Phase II/III, Open Label, Non-Randomized, Multi - Center Study Of Positron Emission Tomography (PET) Imaging With [F-18] FLT Compared to [F-18] FDG in Cancer Patients for Treatment Evaluation
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.
;
Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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