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Trial record 54 of 2865 for:    Pancreatic Cancer

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

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ClinicalTrials.gov Identifier: NCT01542177
Recruitment Status : Recruiting
First Posted : March 2, 2012
Last Update Posted : May 6, 2019
Sponsor:
Collaborator:
Canadian Cancer Society Research Institute (CCSRI)
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date January 5, 2012
First Posted Date March 2, 2012
Last Update Posted Date May 6, 2019
Study Start Date February 2012
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 1, 2012)
Measure the hypoxia level in Patients with Pancreatic Cancer using Positron Emission Tomography (PET) with 18F-Fluoroazomycin Arabinoside (18F-FAZA). [ Time Frame: 2 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01542177 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 1, 2012)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study Using 18F-FAZA and PET Scans to Study Hypoxia in Pancreatic Cancer
Official Title The Evaluation of Hypoxia Imaging in Patients With Pancreatic Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA)
Brief Summary 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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
2 tubes of whole blood
Sampling Method Probability Sample
Study Population Pancreatic cancer
Condition
  • Pancreatic Cancer
  • Hypoxia
Intervention Not Provided
Study Groups/Cohorts Pancreatic cancer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 1, 2012)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2019
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Prachi Mohite 416-946-4501 prachi.mohite@uhn.ca
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT01542177
Other Study ID Numbers FAZA-Pancreas
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor University Health Network, Toronto
Collaborators Canadian Cancer Society Research Institute (CCSRI)
Investigators
Principal Investigator: David Hedley, MD Princess Margaret Hospital, Canada
PRS Account University Health Network, Toronto
Verification Date May 2019