Clinical trial NCT00756691: A Radiopharmacokinetic and Radiodosimetric Phase I Imaging Study of 18F-FAZA
Official title: A Radiopharmacokinetic and Radiodosimetric Phase I Imaging Study of 18F-FAZA
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hypoxic Tumours
Keywords: 18F-FAZA
Positron Emission Tomography
Radiation dosimetry
Pharmacokinetics
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2008-09-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with known primary or suspected metastatic carcinoma of the following: squamous cell carcinoma (SCC) of the head and neck, small (SCLC) and non-small cell lung cancer(NSCLC), Glioblastoma multiforme (GBM), lymphoma, or neuroendocrine tumours (NET).

Brief summary: Hypoxia (little of no oxygen) is considered to be an important characteristic of a patient's tumour that may help predict patient outcomes and/or help inform patient management decisions. 18F-FAZA Positron Emission Tomography (PET) can detect hypoxic tumours because 18F-FAZA accumulates in hypoxic tissues. This study is being done to learn more about the processes by which 18F-FAZA is absorbed, distributed, metabolized (built-up and broken down) and eliminated by the body.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: To Collect imaging-based data for radiopharmacokinetic and radiodosimetric analyses.
timeFrame: 2 years
Secondary outcomes:
measure: To determine radiation dosimetry and optimal imaging times
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Professor, Department of Oncology
name: Alexander McEwan, MB, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: