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A Radiopharmacokinetic and Radiodosimetric Phase I Imaging Study of 18F-FAZA

18 Years
Open (Enrolling)
Hypoxic Tumours

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Trial Information

A Radiopharmacokinetic and Radiodosimetric Phase I Imaging Study of 18F-FAZA

A Phase I Radiopharmacokinetic and Radiodosimetric study of 18F-FAZA. Prior to treatment,
subjects will receive a single injection of 18F-FAZA. Subjects will undergo a series of 5-5
PET scans, and will have 8-13 blood samples and 2 urine samples taken at specified time
points over a 4.5-5.5 hour period. 18F-FAZA PET images will be reviewed to develop a
dynamic uptake model, and blood and urine samples will be analyzed for unchanged 18F-FAZA
and its metabolites.

Inclusion Criteria:

- Male of Female > or = to 18 years of age. If female of child-bearing potential and
outside of the window of 10 days since the first day of the last menstrual period, a
negative pregnancy test required

- Subjects with known primary or suspected metastatic SCC head and neck; NSCLC; SCLC;
GBM; lymphoma, or NET with at least one lesion > 1 cm in diameter

- Able and willing to follow instructions and comply with the protocol

- Provide written informed consent prior to participation in the study

- Karnofsky Performance Scale Score of 70-100

Exclusion Criteria:

- Previous treatment for their primary or metastatic SCC head and neck, NSCLC, SCLC,
GBM, Lymphoma, or NET

- Bilirubin > or = to 200 umol/L

- Creatinine > or - to 150 umol/L

- AST or ALT > or = to 5 times the upper limits of normal

- Serious medical conditions such as: congestive heart failure, unstable angina,
unstable ventricular arrhythmia, uncontrolled psychiatric conditions, serious
infections, uncontrolled diabetes

- Nursing or pregnant females

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

To Collect imaging-based data for radiopharmacokinetic and radiodosimetric analyses.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Alexander J. B. McEwan, MD, FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Alberta Health Services


Canada: Health Canada

Study ID:




Start Date:

October 2008

Completion Date:

November 2012

Related Keywords:

  • Hypoxic Tumours
  • 18F-FAZA
  • Positron Emission Tomography
  • Radiation dosimetry
  • Pharmacokinetics