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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by AHS Cancer Control Alberta
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00756691
First received: September 19, 2008
Last updated: June 4, 2014
Last verified: June 2014
  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:


Further study details as provided by AHS Cancer Control Alberta:

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 2014
Estimated Primary Completion Date: October 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Lai Schrader 780-432-8464 Lai.Schrader@albertahealthservices.ca

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

No publications provided

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00756691     History of Changes
Other Study ID Numbers: SP-24367
Study First Received: September 19, 2008
Last Updated: June 4, 2014
Health Authority: Canada: Health Canada

Keywords provided by AHS Cancer Control Alberta:
18F-FAZA
Positron Emission Tomography
Radiation dosimetry
Pharmacokinetics

ClinicalTrials.gov processed this record on August 28, 2014