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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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01326364
First Posted: March 30, 2011
Last Update Posted: July 1, 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. Read our disclaimer for details.
Information provided by (Responsible Party):
Stanford University
  Purpose
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.

Condition Intervention
Pancreatic Cancer Procedure: Stereotactic body radiotherapy Drug: Iodixanol Drug: Iohexol

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Value of Baseline CT Perfusion Parameters of Pancreatic Cancer for Patients Undergoing Stereotactic Body Radiotherapy or Surgical Resection

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 ]

Enrollment: 6
Study Start Date: March 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  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:   Non-Probability Sample
Study Population
pancreatic adenocarcinoma
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.

  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): NCT01326364


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Aya Kamaya Stanford University
  More Information

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01326364     History of Changes
Other Study ID Numbers: PANC0009
SU-03182010-5282 ( Other Identifier: Stanford University )
First Submitted: April 14, 2010
First Posted: March 30, 2011
Last Update Posted: July 1, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases