NCT00588367

Brief Summary

  1. 1.Pancreatic CT perfusion with a biofeedback breathing belt worn by the participant, and using novel post-processing techniques, is a reliable method which can be used to differentiate between pancreatic cancer, chronic pancreatitis, and autoimmune pancreatitis.
  2. 2.Pancreatic CT perfusion can be used to monitor patients undergoing decompression treatment (endoscopic retrograde cholangiopancreatography with stent placement) for painful chronic pancreatitis, and the change in the pancreatic perfusion parameters correlate with the change in the pain parameters (pain scale and analgesic use).
  3. 3.Pancreatic CT perfusion parameters can be calculated using surrogate scan data sets at specific time points to replace the continuous scanning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 24, 2007

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 8, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

2.8 years

First QC Date

December 24, 2007

Last Update Submit

April 14, 2015

Conditions

Pancreatic Ductal AdenocarcinomaChronic PancreatitisAutoimmune Pancreatitis

Keywords

InflammationPancreasChronic pancreatitisAlcoholic pancreatitisCarcinoma, pancreatic ductalPancreatic neoplasms

Outcome Measures

Primary Outcomes (1)

  • A reproducible technique to measure CT perfusion parameters may provide a method for non-invasively monitoring tumor response during treatment, or differentiating between autoimmune and chronic pancreatitis.

    Three weeks to three months for chronic pancreatitis.

Study Arms (3)

1

Suspected pancreatic ductal adenocarcinoma.

Device: Mayo Interactive Breath Hold Monitor

2

Chronic pancreatitis and slated for decompression treatment.

Device: Mayo Interactive Breath Hold Monitor

3

Autoimmune pancreatitis.

Device: Mayo Interactive Breath Hold Monitor

Interventions

Mayo Interactive Breath Hold MonitorDEVICE

Biofeedback device

123

Eligibility Criteria

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

Mayo Clinic patients being seen in Pancreas Clinic.

You may qualify if:

  • a. Suspected pancreatic adenocarcinoma, age 35 to 99 years.
  • a. Chronic pancreatitis with chronic pain, age 18 to 99 years. Must be a confirmed diagnosis by either CT, endoscopic ultrasound (EUS), or endoscopic retrograde cholangiopancreatography (ERCP).
  • b. To undergo endoscopic or surgical decompression with 0 to 10 days of first study visit CT perfusion scan.
  • c. To answer pain questionnaire before first CT perfusion scan.
  • d. To return within three weeks to three months after decompression treatment for another CT perfusion scan and complete the second pain questionnaire.
  • a. Autoimmune pancreatitis, age 18 to 99 years either with diffuse or focal swelling of the pancreas confirmed by CT, MRI, or EUS or
  • b. Irregular narrowing of the pancreatic duct on ERCP and either elevated serum immunoglobulin G4 (IgG4), or histological confirmation.

You may not qualify if:

  • a. Pancreatic ductal adenocarcinoma tumors with vascular involvement but without vascular occlusion.
  • b. Pancreatic ductal adenocarcinoma tumors less than 2 cm in size.
  • a. Chronic pancreatitis with diffuse and extensive pancreatic calcification.
  • a. Autoimmune pancreatitis with a prior pancreas surgery or steroid treatment for autoimmune pancreatitis .
  • Any Cohort:
  • \. Pregnant.
  • \. Prior iodine contrast reactions.
  • \. Iodine allergy.
  • \. Decreased kidney function being a serum creatinine greater than 1.5mg/dl.
  • \. Any contraindication to having a CT scan with iodine contrast.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pancreatitis, ChronicAutoimmune PancreatitisInflammationPancreatitis, AlcoholicCarcinoma, Pancreatic DuctalPancreatic Neoplasms

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAutoimmune DiseasesImmune System DiseasesAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersCarcinoma, DuctalAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Ductal, Lobular, and MedullaryDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsEndocrine System Diseases

Study Officials

  • Naoki Takahashi, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 24, 2007

First Posted

January 8, 2008

Study Start

April 1, 2006

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

April 15, 2015

Record last verified: 2015-04

Locations

US(1)