Conditions: Lung Cancer Head and Neck Cancer
Keywords: lung cancer head and neck cancer radiotherapy chemoradiotherapy radiation chemoradiation FLT [F-18]FLT FDG [F-18]FDG
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 49
Healthy volunteers: no

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.

Arms:
arm 1: Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate \[F-18\] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard \[F-18\] FDG PET will be the active comparator.

Interventions: intervention 1: [F-18]FLT
Intervention descriptions: intervention 1: 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.

Protocol document: