Positron Emission Tomography Imaging With [F-18] FLT Compared to [F-18] FDG in Cancer Patients for Treatment Evaluation
- Conditions
- Head and Neck Cancer
- Interventions
- Drug: [F-18] FLT
- Registration Number
- NCT00894101
- Lead Sponsor
- University of California, Irvine
- Brief Summary
The purpose of this study is to investigate the clinical value of serial quantitative \[F-18\] FLT as a PET imaging tool in head and neck cancer patients clinically scheduled with radiation or radiation-chemotherapy combination in terms of safety and efficacy. Standard \[F-18\] FDG PET will be the active comparator.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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Patient provides written Informed Consent and is willing to comply with protocol requirements
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Patient is at least 18 years of age on the day of dosing (male or female of any race or ethnicity)
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Patient is capable of lying still in the PET scanner for the protocol required time frame(s)
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Patient has a diagnosis of one of the following malignancies (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)
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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
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Patient is scheduled to start radiotherapy or a chemoradiotherapy regimen for curative intent
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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)
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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
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Patient has not received or intends to receive 5-fluorouracil (5-FU-chemotherapeutic agent)
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Patient has a score of greater than or equal to (≥) 60% on the Karnofsky Performance Status Scale
Exclude a patient from this study if the patient does not fulfill the inclusion criteria, or if any of the following conditions are observed:
-
Patient is a pregnant or lactating female. These methods will be used to 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.
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Patient is undergoing treatment with palliative intent
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Patient has received an investigational compound and/or medical device within 14 days before admission into this study
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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
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Patient is determined by the Investigator that he/she is clinically unsuitable for the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description [F-18] FLT and FDG [F-18] FLT -
- Primary Outcome Measures
Name Time Method The basic safety data of [F-18] FLT tracer will be collected. The treatment response evaluated based on the [F-18] FLT results will be compared to the response evaluated based on the standard PET trace [F-18] FDG. 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Radiology, UCI Medical Center
🇺🇸Orange, California, United States