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Prognostic Value of Baseline Computed Tomography (CT) Perfusion Parameters of Pancreatic Cancer for Patients Undergoing Stereotactic Body Radiotherapy or Surgical Resection

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01326364
Recruitment Status : Terminated
First Posted : March 30, 2011
Last Update Posted : July 1, 2016
Sponsor:
Information provided by (Responsible Party):
Stanford University

Tracking Information
First Submitted Date April 14, 2010
First Posted Date March 30, 2011
Last Update Posted Date July 1, 2016
Study Start Date March 2010
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 29, 2011)
  • Histological markers of tumor angiogenesis (microvessel density, EGF/VEGF expression level) [ Time Frame: 1 day ]
  • Tumor response to treatment in SBRT patients, based on WHO criteria (No Change/Progressive Disease vs. Partial/Complete Response) [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prognostic Value of Baseline Computed Tomography (CT) Perfusion Parameters of Pancreatic Cancer for Patients Undergoing Stereotactic Body Radiotherapy or Surgical Resection
Official Title Prognostic Value of Baseline CT Perfusion Parameters of Pancreatic Cancer for Patients Undergoing Stereotactic Body Radiotherapy or Surgical Resection
Brief Summary The purpose of this study is first, to determine whether baseline perfusion characteristics of pancreatic cancer, as characterized by CT perfusion studies, can predict tumor response to treatment by stereotactic body radiotherapy (SBRT). The second goal of this study is to determine whether baseline perfusion characteristics in those patients with resectable pancreatic cancer correlate with immunohistologic markers of angiogenesis such as microvessel density and vascular endothelial growth factor (VEGF) expression.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population pancreatic adenocarcinoma
Condition Pancreatic Cancer
Intervention
  • Procedure: Stereotactic body radiotherapy
    Standard of Care
    Other Name: CyberKnife
  • Drug: Iodixanol
    IV, calculated per patient
    Other Name: Visipaque
  • Drug: Iohexol
    IV, Calculated per patient
    Other Name: Omnipaque
Study Groups/Cohorts Not Provided
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 Terminated
Actual Enrollment
 (submitted: June 30, 2016)
6
Original Estimated Enrollment
 (submitted: March 29, 2011)
50
Actual Study Completion Date June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. suspected and/or biopsy-proven pancreatic adenocarcinoma, and
  2. referral to Radiology for pre-treatment baseline pancreatic protocol CT.

Exclusion criteria:

1) are absolute contraindications to intravenous iodinated contrast or CT scan.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01326364
Other Study ID Numbers PANC0009
SU-03182010-5282 ( Other Identifier: Stanford University )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Stanford University
Study Sponsor Stanford University
Collaborators Not Provided
Investigators
Principal Investigator: Aya Kamaya Stanford University
PRS Account Stanford University
Verification Date June 2016