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

NCT00756691 | Withdrawn

• 1 other identifier: PK-FAZ-003
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypoxic Tumours

Keywords

18F-FAZA; Positron Emission Tomography; Radiation dosimetry; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

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

  2 years

Secondary Outcomes (1)

• To determine radiation dosimetry and optimal imaging times

  2 years

Study Arms (2)

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

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

Interventions

18F-FAZA OTHER

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

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead

MeSH Terms

Interventions

fluoroazomycin arabinoside

Study Officials

• Alexander McEwan, MB, FRCPC

  Professor, Department of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2008
• First Posted: September 22, 2008
• Last Updated: November 14, 2017

Record last verified: 2017-11