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

AHS Cancer Control Alberta

Overview

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.

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.

Study Type

OBSERVATIONAL

Conditions

Hypoxic Tumours

Interventions

18F-FAZAOTHER

Radioactive dose of 110-600 MBq per injection. A single pre-treatment injection of 18F-FAZA will be permitted per patient

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 2 years

Secondary Outcomes

To determine radiation dosimetry and optimal imaging times

Time frame: 2 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.