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

This study is currently recruiting participants.
Verified June 2016 by University Health Network, Toronto
Sponsor:
ClinicalTrials.gov Identifier:
NCT01542177
First Posted: March 2, 2012
Last Update Posted: June 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Canadian Cancer Society Research Institute (CCSRI)
Information provided by (Responsible Party):
University Health Network, Toronto
  Purpose
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.

Condition
Pancreatic Cancer Hypoxia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Evaluation of Hypoxia Imaging in Patients With Pancreatic Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA)

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Measure the hypoxia level in Patients with Pancreatic Cancer using Positron Emission Tomography (PET) with 18F-Fluoroazomycin Arabinoside (18F-FAZA). [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Correlate FAZA PET uptake in pancreatic cancer with the extension of the disease. [ Time Frame: 2 years ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]

Biospecimen Retention:   None Retained
2 tubes of whole blood

Estimated Enrollment: 30
Study Start Date: February 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pancreatic cancer

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pancreatic cancer
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542177


Contacts
Contact: Prachi Mohite 416-946-4501 prachi.mohite@uhn.ca

Locations
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Principal Investigator: David Hedley, MD         
Sponsors and Collaborators
University Health Network, Toronto
Canadian Cancer Society Research Institute (CCSRI)
Investigators
Principal Investigator: David Hedley, MD Princess Margaret Hospital, Canada
  More Information

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01542177     History of Changes
Other Study ID Numbers: FAZA-Pancreas
First Submitted: January 5, 2012
First Posted: March 2, 2012
Last Update Posted: June 22, 2016
Last Verified: June 2016

Keywords provided by University Health Network, Toronto:
hypoxia
pancreas
cancer
pancreatic cancer
18F-FAZA
18F-Fluoroazomycin Arabinoside
Positron Emission Tomography
PET

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Hypoxia
Digestive System Diseases
Endocrine System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms