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The Evaluation of Hypoxia Imaging in Patients With Pancreatic Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA)


N/A
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer, Hypoxia

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Trial Information

The Evaluation of Hypoxia Imaging in Patients With Pancreatic Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA)


This is a single centre, single arm hypoxia study of pancreatic cancer with PET FAZA
imaging.

PET-CT imaging of tumor hypoxia with FAZA will be done prior to the start of standard
treatment for pancreatic cancer with chemotherapy. The FAZA PET-CT imaging session will last
approximately 2.5 hours and include an initial dynamic scan to completely characterize the
initial rapid phase of FAZA uptake, followed by a later static scan.


Inclusion Criteria:



- Minimum age of 18 years old

- Histologic diagnosis of pancreatic adenocarcinoma

- TNM (7th edition) cT1-4, N0-1, M0-1

- No cytotoxic anti-cancer therapy for advanced / metastatic pancreatic cancer prior to
study entry

- Ability to provide written informed consent to participate in the study

- ECOG performance status 0, 1 or 2.

- Patient should have the following blood counts at baseline: ANC equal or greater to
1.5 x 109/L; Platelets equal or greater to 100 x 109/L; Hgb equal or greater to 9g/Dl

- Patient should have the following blood chemistry levels at baseline: AST (SGOT), ALT
(SGPT) equal or less than 5 x upper limit of normal range (ULN) is allowed

- Patient has an identifiable tumor (pancreatic tumor and/or metastasis) by imaging (CT
scan and/or MR)

- Patient must agree to use contraception considered adequate and appropriate by the
investigator and if the patient is female of child-bearing potential, as evidenced by
regular menstrual periods, she must have a negative serum pregnancy test (B-hCG)

Exclusion Criteria:

- Inability to lie supine for more than 30 minutes

- Any other type of primary cancer

- Life expectancy of less than 12 weeks

- Patient has known brain metastases unless previously treated and well controlled for
at least 3 months (defined as stable clinically, no edema, no steroids and stable in
two scans at least 4 weeks apart)

- Patient has serious medical risk factors involving any of the major organ systems

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Measure the hypoxia level in Patients with Pancreatic Cancer using Positron Emission Tomography (PET) with 18F-Fluoroazomycin Arabinoside (18F-FAZA).

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

David Hedley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital, Canada

Authority:

Canada: Health Canada

Study ID:

FAZA-Pancreas

NCT ID:

NCT01542177

Start Date:

February 2012

Completion Date:

April 2015

Related Keywords:

  • Pancreatic Cancer
  • Hypoxia
  • hypoxia
  • pancreas
  • cancer
  • pancreatic cancer
  • 18F-FAZA
  • 18F-Fluoroazomycin Arabinoside
  • Positron Emission Tomography
  • PET
  • Pancreatic Neoplasms
  • Anoxia

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