Status:
COMPLETED
A Multi - Center Study Of PET Imaging With [F-18] FLT & [F-18] FDG in Cancer Patients for Treatment Evaluation
Lead Sponsor:
Siemens Molecular Imaging
Conditions:
Lung Cancer
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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-flu...
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...
Eligibility Criteria
Inclusion
- Patient provides written Informed Consent and is willing to comply with protocol requirements
- Patient is at least 18 years of age on the day of dosing (male or female of any race or ethnicity)
- Patient is capable of lying still in the PET scanner for the protocol required time frame(s)
- Patient has a diagnosis of one of the following malignancies using the TNM Staging System:
- Lung cancer (T3 grade up, node positive, but no metastatic disease)
- Head and neck cancer (T3 grade up, node positive, but no metastatic disease)
- Patient has undergone a comparative, diagnostic procedure with lesion(s) visible, other than ultrasound, that includes, but is not limited to computed tomography (CT), magnetic resonance imaging (MRI), nuclear medicine imaging, endoscopy, laparoscopy, standard abdominal x-ray, biopsy and/or surgery for one of the above mentioned areas
- Patient is scheduled to start radiotherapy or a chemoradiotherapy regimen for curative intent
- As a part of his/her standard radiotherapy or chemoradiotherapy regimen, patient is scheduled to have clinical \[F-18\]FDG PET scans pre treatment and post treatment (at about 4 weeks (±1 week) after the start of therapy)
- Patient is scheduled to have the investigational, pre treatment \[F-18\] FLT PET scan recommended to be within ± 2 days of the clinical, pre treatment \[F-18\] FDG PET scan
- Patient has not received or intends to receive 5-fluorouracil (chemotherapeutic agent)
- Patient has a score of greater than or equal to (\>/=) 60% on the Karnofsky Performance Status Scale
Exclusion
- Patient is a pregnant or lactating female. Exclude the possibility of pregnancy:
- by testing on site at the institution (serum or urine βHCG) within 48 hours prior to the start of each investigational product administration
- by surgical history (eg, tubal ligation or hysterectomy)
- by patient's history of being post menopausal with a minimum 1 year without menses
- Patient is undergoing treatment with palliative intent
- Patient has received an investigational compound and/or medical device within 14 days before admission into this study
- Patient has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations
- Patient is determined by the Investigator that he/she is clinically unsuitable for the study.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00847509
Start Date
February 1 2009
End Date
September 1 2010
Last Update
September 27 2013
Active Locations (2)
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1
Hoag Memorial Hospital
Newport Beach, California, United States, 92658
2
Excel Diagnostics Imaging Clinics
Houston, Texas, United States, 77042