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Brief Title: A Multi - Center Study Of PET Imaging With [F-18] FLT & [F-18] FDG in Cancer Patients for Treatment Evaluation
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
Study ID: NCT00847509
Brief 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hoag Memorial Hospital, Newport Beach, California, United States
Excel Diagnostics Imaging Clinics, Houston, Texas, United States
Name: Ebrahim S Delpassand, MD
Affiliation: Excel Diagnostics Imaging Clinics
Role: PRINCIPAL_INVESTIGATOR
Name: Michael Brandt-Zawadzki, MD
Affiliation: Hoag Memorial Hospital, Newport Beach, CA
Role: PRINCIPAL_INVESTIGATOR