NCT01326364

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 14, 2010

Completed
12 months until next milestone

First Posted

Study publicly available on registry

March 30, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 1, 2016

Status Verified

June 1, 2016

Enrollment Period

2.3 years

First QC Date

April 14, 2010

Last Update Submit

June 30, 2016

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

  • Histological markers of tumor angiogenesis (microvessel density, EGF/VEGF expression level)

    1 day

  • Tumor response to treatment in SBRT patients, based on WHO criteria (No Change/Progressive Disease vs. Partial/Complete Response)

    1 year

Interventions

Stereotactic body radiotherapyPROCEDURE

Standard of Care

Also known as: CyberKnife
IodixanolDRUG

IV, calculated per patient

Also known as: Visipaque
IohexolDRUG

IV, Calculated per patient

Also known as: Omnipaque

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

pancreatic adenocarcinoma

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

RadiosurgeryiodixanolIohexol

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative TechniquesTriiodobenzoic AcidsIodobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Aya Kamaya

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2010

First Posted

March 30, 2011

Study Start

March 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 1, 2016

Record last verified: 2016-06

Locations

US(1)