Positron Emission Tomography Imaging With [F-18] FLT Compared to [F-18] FDG in Cancer Patients for Treatment Evaluation
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2/Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: [F-18] FLT and FDG
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Drug: [F-18] FLT
10 mCi [F-18] FLT and 10 mCi [F-18] FDG will be used for PET imaging.
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Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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):
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Lung cancer (T3 grade up, node positive, but no metastatic disease)
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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
Exclusion Criteria:
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:
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by testing on site at the institution (serum or urine βHCG) within 48 hours prior to the start of each investigational product administration,
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by surgical history (eg, tubal ligation or hysterectomy),
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Department of Radiology, UCI Medical Center | Orange | California | United States | 92868 |
Sponsors and Collaborators
- University of California, Irvine
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HS# 2009-6857