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
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
To measure if the clinical value with quantitative [F-18] FLT PET positron images for tumor proliferation rates for early assessment of tumor response to radiation or chemoradiotherapy regimens in comparison to quantitative [F-18] FDG PET images
3-5 weeks after the start of radiation or chemo radio therapy
No
Ebrahim S Delpassand, MD
Principal Investigator
Excel Diagnostics Imaging Clinics
United States: Food and Drug Administration
FLT101
NCT00847509
February 2009
September 2010
Name | Location |
---|---|
HOAG Memorial Hospital | Newport Beach, California 92658-6100 |
Excel Diagnostics Imaging Clinics | Houston, Texas 77042 |