TheranosticTrials.org

Clinical Trial · NCT00894101

Positron Emission Tomography Imaging With [F-18] FLT Compared to [F-18] FDG in Cancer Patients for Treatment Evaluation

Overview

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.

Sponsor

University of California, Davis

Phase

Phase 2/3

ClinicalTrials.gov

NCT00894101

Drug / Compound

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

FLT

Isotope(s):
Target(s):
  • cytosolic thymidine kinase 1
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Lung cancer (T3 grade up, node positive, but no metastatic disease)
  • 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 has a diagnosis of one of the following malignancies (TNM Staging System):
  • 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 capable of lying still in the PET scanner for the protocol required time frame(s)
  • Patient has not received or intends to receive 5-fluorouracil (5-FU-chemotherapeutic agent)
  • Patient has a score of greater than or equal to (≥) 60% on the Karnofsky Performance Status Scale
  • 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 is scheduled to start radiotherapy or a chemoradiotherapy regimen for curative intent

Exclusion

  • Exclude a patient from this study if the patient does not fulfill the inclusion criteria, or if any of the following conditions are observed:
  • by surgical history (eg, tubal ligation or hysterectomy),
  • by patient's history of being post menopausal with a minimum 1 year without menses.
  • 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 undergoing treatment with palliative intent
  • by testing on site at the institution (serum or urine βHCG) within 48 hours prior to the start of each investigational product administration,
  • Patient is a pregnant or lactating female. These methods will be used to exclude the possibility of pregnancy:
  • Patient is determined by the Investigator that he/she is clinically unsuitable for the study.
  • Patient has received an investigational compound and/or medical device within 14 days before admission into this study