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Early Increase in Blood Flow (EIBS) in the Duodenum in Patients With Pancreatic Cancer

NCT01015820 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2014-07-16

Study results available
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Summary

Pancreatic cancer is the fourth leading cause of cancer death in the United States and is associated with a poor prognosis. The average life expectancy after diagnosis is approximately 5 to 8 months. At present, successful surgical resection is the only curative therapy that can improve long-term survival. However, it can be achieved only when a tumor is detected at an early stage. Unfortunately, due to non-specific symptoms associated with pancreatic cancer, it is commonly detected in the later stages of the disease.

The investigators hypothesized that pancreatic cancer could be detected by measuring the changes in the early increase in blood supply (EIBS) found in the surrounding normal-appearing duodenal tissue. The investigators tested a device called Four-dimensional Elastic Light-Scattering Fingerprinting (4D-ELF). The device used in this study is considered investigational, which means it has either not been approved by the Food and Drug Administration (FDA) for routine clinical use or for the use described in this study. However the FDA allowed the use of this device in this research study.

Conditions

Interventions

PROCEDURE

EGD with EUS

EUS was performed in order to measure blood flow in duodenum.

DEVICE

4D-ELF

During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.

Sponsors & Collaborators

  • Northwestern University

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Michael B. Wallace, MD MPH · Mayo Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01015820 on ClinicalTrials.gov