NCT00847509

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Siemens Molecular Imaging · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer
• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	[F-18]FLT	The individual doses of \[F-18\]FLT contain a maximum of 10 mCi. The single IP dose is administered to the study subject approximately 30 to 60 minutes prior to the start of PET imaging.

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-08-01
• Completion: 2010-09-01
• First posted: 2009-02-19
• Last updated: 2013-09-27
• Results posted: 2013-09-27

Locations

2 sites across 1 country: United States