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

This study is currently recruiting participants.
Verified April 2012 by Alberta Health Services
Sponsor:
Information provided by (Responsible Party):
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00756691
First received: September 19, 2008
Last updated: April 9, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
Hypoxic Tumours
 Other: 18F-FAZA

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Radiopharmacokinetic and Radiodosimetric Phase I Imaging Study of 18F-FAZA

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Alberta Health Services:

Primary Outcome Measures:
  • To Collect imaging-based data for radiopharmacokinetic and radiodosimetric analyses. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine radiation dosimetry and optimal imaging times [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2008
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
First 5 consecutive 18F-FAZA avid subjects that undergo up to 5 PET scans, 13 blood and 2 urine samples over 4.5 hours
 Other: 18F-FAZA
Radioactive dose of 110-600 MBq per injection. A single pre-treatment injection of 18F-FAZA will be permitted per patient
2
Next 5 consecutive 18F-FAZA avid subjects that undergo up to 4 PET scans, 8 blood and 2 urine samples over 5.5 hours
 Other: 18F-FAZA
Radioactive dose of 110-600 MBq per injection. A single pre-treatment injection of 18F-FAZA will be permitted per patient

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00756691

Contacts
Contact: Lai Schrader 780-432-8464 laischra@cancerboard.ab.ca

Locations
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact     708-432-8464     clinical_trials_cci@cancerboard.ab.ca    
Principal Investigator: Alexander J. B. McEwan, MD, FRCPC            
Sub-Investigator: Steve McQuarrie, PhD            
Sub-Investigator: Leonard I. Wiebe, DSc, PhD            
Sponsors and Collaborators
Alberta Health Services
Investigators
Principal Investigator: Alexander J. B. McEwan, MD, FRCPC Alberta Health Services
  More Information

No publications provided

Responsible Party: Alberta Health Services
ClinicalTrials.gov Identifier: NCT00756691     History of Changes
Other Study ID Numbers: SP-24367
Study First Received: September 19, 2008
Last Updated: April 9, 2012
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
18F-FAZA
Positron Emission Tomography
Radiation dosimetry
Pharmacokinetics

ClinicalTrials.gov processed this record on May 21, 2013