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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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01326364
First received: April 14, 2010
Last updated: April 23, 2013
Last verified: April 2013
History of Changes
  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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
  • Tumor response to treatment in SBRT patients, based on WHO criteria (No Change/Progressive Disease vs. Partial/Complete Response) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2010
Estimated Study Completion Date: September 2015
Primary Completion Date: June 2011 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01326364     History of Changes
Other Study ID Numbers: PANC0009, SU-03182010-5282
Study First Received: April 14, 2010
Last Updated: April 23, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 17, 2013