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A Phase I/II Imaging Study of 1-a-D-(5-deoxy-5-[18]F-fluoroarabinofuranosyl)-2-nitroimidazole ([18]F-FAZA) in Patients With Known Squamous Cell Carcinoma of the Head & Neck, Small Cell and Non-Small Cell Carcinoma of the Lung, Lymphoma, Glioblastoma Multiforme, Neuroendocrine Tumours or Renal Cell Carcinoma


Phase 1/Phase 2
16 Years
N/A
Open (Enrolling)
Both
Renal Cell Carcinoma, Neuroendocrine Tumours

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Trial Information

A Phase I/II Imaging Study of 1-a-D-(5-deoxy-5-[18]F-fluoroarabinofuranosyl)-2-nitroimidazole ([18]F-FAZA) in Patients With Known Squamous Cell Carcinoma of the Head & Neck, Small Cell and Non-Small Cell Carcinoma of the Lung, Lymphoma, Glioblastoma Multiforme, Neuroendocrine Tumours or Renal Cell Carcinoma


The proposed clinical trial will be a Phase I/II imaging, open label, single site study. In
Phase I, one 18F-FAZA PET scan will be conducted in patients with known squamous cell
carcinoma of the Head & Neck, SCLC, NSCLC, lymphoma, GGM, neuroendocrine tumours or renal
cell carcinoma. In Phase II, three 18F-FAZA PET scans will be done on patients with the
above tumours as follows: one pre-treatment, one mid course and one post-treatment.


Inclusion Criteria:



- Male or female greater than or equal to 16 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 is required.

- Patients with known primary or suspected metastatic squamous cell carcinoma of the
head and neck, non-small cell or small cell carcinoma of the lung, lymphoma, GBM
(greater than or equal to 3 glioma), neuroendocrine tumours, or renal cell carcinoma
with at least one lesion >1 cm in diameter.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Phase I: demonstrate the safety of 18F-FAZA manufactured at the Edmonton Radiopharmaceutical Centre/Edmonton PET Centre. Phase II: determine the general biodistribution pattern of18F-FAZA.

Outcome Description:

Phase I: Pre-injection and post-imaging vital signs, blood haematology and blood chemistry, adverse event collection. Phase II: The location and relative uptake of normal and abnormal 18F-FAZA biodistribution patterns will be determined.

Outcome Time Frame:

Phase I: 2 years, Phase II: 5 years

Safety Issue:

Yes

Principal Investigator

Alexander J.B. McEwan, MB, MSc, BS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cross Cancer Institute

Authority:

Canada: Health Canada

Study ID:

SP-14-0050/DX-FAZ-001/22390

NCT ID:

NCT00323076

Start Date:

September 2004

Completion Date:

August 2012

Related Keywords:

  • Renal Cell Carcinoma
  • Neuroendocrine Tumours
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Renal Cell
  • Carcinoma, Squamous Cell
  • Lymphoma
  • Neuroendocrine Tumors
  • Head and Neck Neoplasms
  • Glioblastoma

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