Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study Using 18F-FAZA and PET Scans to Study Hypoxia in Pancreatic Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by University Health Network, Toronto
Sponsor:
Collaborator:
Canadian Cancer Society Research Institute (CCSRI)
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01542177
First received: January 5, 2012
Last updated: March 2, 2015
Last verified: March 2015

January 5, 2012
March 2, 2015
February 2012
June 2015   (final data collection date for primary outcome measure)
Measure the hypoxia level in Patients with Pancreatic Cancer using Positron Emission Tomography (PET) with 18F-Fluoroazomycin Arabinoside (18F-FAZA). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01542177 on ClinicalTrials.gov Archive Site
  • Correlate FAZA PET uptake in pancreatic cancer with the extension of the disease. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Standardized uptake statistics will be calculated for each volume of interest (VOI): Maximum standardized uptake value (SUVMax), mean standardized uptake value (SUVMean) and standard deviation of standardized uptake values (SUVSD).
  • Correlate FAZA PET uptake in pancreatic cancer with CA 19-9 levels. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Standardized uptake statistics will be calculated for each volume of interest (VOI): Maximum standardized uptake value (SUVMax), mean standardized uptake value (SUVMean) and standard deviation of standardized uptake values (SUVSD). These parameters will be correlated with increasing or decreasing CA 19-9 levels (U/ml).
  • Correlate FAZA PET uptake in pancreatic cancer with tumor response. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Standardized uptake statistics will be calculated for each volume of interest (VOI): Maximum standardized uptake value (SUVMax), mean standardized uptake value (SUVMean) and standard deviation of standardized uptake values (SUVSD). Tumor response is measured in millimeters. Complete response is a tumor reduction of <5 mm, partial response is at least a 30% reduction, progressive disease is a 20% increase, and stable disease is no increase in shrinkage and no increase in growth.
  • Correlate FAZA PET uptake in pancreatic cancer with patient disease-free survival (DFS). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Kaplan-Meier actuarial method and/or the Cox proportional hazard model will be utilized.
  • Compare the pattern of FAZA uptake in different tumor sites (eg., lymph node metastases and liver metastasis). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Standardized uptake statistics will be calculated for each volume of interest (VOI): Maximum standardized uptake value (SUVMax), mean standardized uptake value (SUVMean) and standard deviation of standardized uptake values (SUVSD).
  • Determine the feasibility of using dynamic and static PET imaging of FAZA uptake in patients with pancreatic cancer. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study Using 18F-FAZA and PET Scans to Study Hypoxia in Pancreatic Cancer
The Evaluation of Hypoxia Imaging in Patients With Pancreatic Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA)

This is a diagnostic study to look for low levels of oxygen (hypoxia) in pancreatic cancer using an imaging test called positron emission tomography (PET). Hypoxia can influence how pancreatic cancer grows and responds to treatments such as chemotherapy and radiotherapy. The use of PET scans to measure hypoxia may be better and simpler than the approaches used previously. This study will assess whether or not PET scans using a tracer called 18F-FAZA (18F-Fluoroazomycin Arabinoside) can provide useful information about hypoxia in pancreatic cancer. Also as part of the study, a blood sample will be taken to study biomarkers (substances in the body that may be important indicators of hypoxia and/or pancreatic cancer) that may be useful in studying pancreatic cancer and hypoxia.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:

2 tubes of whole blood

Probability Sample

Pancreatic cancer

  • Pancreatic Cancer
  • Hypoxia
Not Provided
Pancreatic cancer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Prachi Mohite 416-946-4501 prachi.mohite@uhn.ca
Canada
 
NCT01542177
FAZA-Pancreas
No
University Health Network, Toronto
University Health Network, Toronto
Canadian Cancer Society Research Institute (CCSRI)
Principal Investigator: David Hedley, MD Princess Margaret Hospital, Canada
University Health Network, Toronto
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP