A Multi - Center Study Of PET Imaging With [F-18] FLT & [F-18] FDG in Cancer Patients for Treatment Evaluation (FLT101)
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|ClinicalTrials.gov Identifier: NCT00847509|
Recruitment Status : Completed
First Posted : February 19, 2009
Results First Posted : September 27, 2013
Last Update Posted : September 27, 2013
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Head and Neck Cancer||Drug: [F-18]FLT||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||February 2009|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||September 2010|
Experimental: FLT PET scan
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.
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.
- [F-18]FLT PET Scan for Early Assessment of Tumor Response to Radiation or Chemoradiotherapy Compared to [F-18] FDG PET Scan [ Time Frame: 3-5 weeks after the start of radiation or chemo radio therapy ]The sponsor decided not to further develop [F-18]FLT. Therefore, no further analysis was performed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00847509
|United States, California|
|Hoag Memorial Hospital|
|Newport Beach, California, United States, 92658|
|United States, Texas|
|Excel Diagnostics Imaging Clinics|
|Houston, Texas, United States, 77042|
|Principal Investigator:||Ebrahim S Delpassand, MD||Excel Diagnostics Imaging Clinics|
|Principal Investigator:||Michael Brandt-Zawadzki, MD||Hoag Memorial Hospital, Newport Beach, CA|