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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01326364
• Other study ID #: PANC0009
• Secondary ID: SU-03182010-5282
• Status: Terminated
• Phase: N/A
• First received: April 14, 2010
• Last updated: June 30, 2016
• Start date: March 2010
• Est. completion date: June 2012

Study information

• Verified date: June 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• Stereotactic body radiotherapy
Standard of Care

Drug:
• Iodixanol
IV, calculated per patient
• Iohexol
IV, Calculated per patient

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histological markers of tumor angiogenesis (microvessel density, EGF/VEGF expression level)		1 day	No
Primary	Tumor response to treatment in SBRT patients, based on WHO criteria (No Change/Progressive Disease vs. Partial/Complete Response)		1 year	No