Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT01015820
Recruitment Status : Completed
First Posted : November 18, 2009
Results First Posted : July 2, 2014
Last Update Posted : July 16, 2014
Sponsor:
Collaborators:
Northwestern University
National Cancer Institute (NCI)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Michael Wallace, Mayo Clinic

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Procedure: EGD with EUS Device: 4D-ELF Not Applicable

Detailed Description:

According to field effect theory, by detecting microvasculature changes in the early increase of blood supply in the surrounding tissue neoplastic lesions can be identified from a distance.

The objective of this study was to determine the feasibility and efficacy of a fiberoptic probe containing novel Polarization Gating Spectroscopy (PGS) technology to identify patients with pancreatic adenocarcinoma (PAC) by field effect theory. EIBS markers, deoxyhemoglobin concentration (DHb), and average blood vessel radius (BVR) were evaluated in patients with PAC versus controls.

During the subjects' esophagogastroduodenoscopy (EGD) with upper endoscopic ultrasound (EUS), the new optic probe was inserted inside the endoscope and advanced to the tip of the endoscope prior to the scope being withdrawn. As the scope was withdrawn, the light optic probe was used to examine approximately 5 sections of the small bowel: 1) directly on the ampulla, 2) approximately 5 mm proximal from the ampulla, 3) approximately 5 mm distal from the ampulla, 4) 1 cm proximal from the ampulla, and 5) 1 cm distal from the ampulla. Spectroscopy measurements were obtained four times in each of these five peri-ampullary locations. The rest of the EGD and upper EUS endoscopy procedures were then completed as clinically indicated. During the procedure, all visualized mucosal abnormalities were recorded and photographed.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Detectable Early Increase in Blood Flow (EIBS) in the Duodenum in Patients With Pancreatic Cancer
Study Start Date : June 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Cancer group
Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
 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.
Control group
Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Deoxyhemoglobin Concentration (DHb) [ Time Frame: Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation ]
    Deoxygenated hemoglobin is the form of hemoglobin without the bound oxygen. It serves as a marker for early increase of blood supply (EIBS). DHb concentration was determined spectroscopically from five peri-ampullary locations.

  2. Mean Blood Vessel Radius (BVR) [ Time Frame: Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation ]
    BVR serves as a marker for early increase of blood supply (EIBS).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or older.
  • Informed written consent.
  • Patient scheduled for previously planned EGD with upper EUS
  • Patients with known adenocarcinoma of the pancreas included in the cancer group
  • Patients with abdominal imaging studies (e.g., CT abdomen or MRI abdomen) negative for malignancy in past 5 years included in the control group.

Exclusion Criteria:

  • Unable to obtain biopsy specimen or fine-needle aspiration results of the pancreas lesion (e.g., coagulation disorder, inadequate sample)
  • Presence of malignant lesion in the pancreas or duodenum other than pancreas adenocarcinoma (e.g., neuroendocrine tumor, gastrointestinal stromal tumor)
  • Known familial disorder with high risk of pancreas cancer development (e.g., familial adenomatous polyposis syndrome, hereditary non-polyposis colorectal cancer syndrome, juvenile polyposis syndrome)
  • Significant family history of pancreatic cancer (at least one first degree relative with pancreatic cancer)
  • Presence of premalignant lesions (e.g., duodenal adenoma, pancreas intraductal papillary mucinous neoplasm)
  • Active visible inflammation/ulcer in the stomach or the duodenum
  • Patients with known chronic pancreatitis were excluded from cancer group. Chronic pancreatitis patients were allowed to be included in the control group only.
  • Known pregnancy or sexually active females of childbearing age who are not practicing an accepted form of birth control.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01015820


Locations
Layout table for location information
United States, Florida
Mayo Clinic Florida
Jacksonville, Florida, United States, 32223
Sponsors and Collaborators
Mayo Clinic
Northwestern University
National Cancer Institute (NCI)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Investigators
Layout table for investigator information
Principal Investigator: Michael B. Wallace, MD MPH Mayo Clinic
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Michael Wallace, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01015820    
Other Study ID Numbers: 09-002596
R01CA128641 ( U.S. NIH Grant/Contract )
R01CA156186 ( U.S. NIH Grant/Contract )
R01EB003682 ( U.S. NIH Grant/Contract )
U01CA111257 ( U.S. NIH Grant/Contract )
CBET-1240416 ( Other Grant/Funding Number: National Science Foundation )
First Posted: November 18, 2009    Key Record Dates
Results First Posted: July 2, 2014
Last Update Posted: July 16, 2014
Last Verified: July 2014
Keywords provided by Michael Wallace, Mayo Clinic:
Pancreatic Cancer
Duodenum
Spectroscopy
Fiberoptic probe
4D-ELF
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases