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

Hypoxic Tumours Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00756691
• Other study ID #: PK-FAZ-003
• Status: Withdrawn
• Phase: N/A
• First received: September 19, 2008
• Last updated: November 10, 2017

Study information

• Verified date: November 2017
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoxic Tumours

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Collect imaging-based data for radiopharmacokinetic and radiodosimetric analyses.		2 years
Secondary	To determine radiation dosimetry and optimal imaging times		2 years