Pancreatic Ductal AdenocarcinomaNCT00588367
CT Pancreas Perfusion
An observational study of Pancreatic Ductal Adenocarcinoma and Chronic Pancreatitis, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma, Chronic Pancreatitis, Autoimmune Pancreatitis
- What is being tested?
- Mayo Interactive Breath Hold Monitor
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Feb 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mayo Clinic patients being seen in Pancreas Clinic.
Who may be able to join
- 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).
- 2b. To undergo endoscopic or surgical decompression with 0 to 10 days of first study visit CT perfusion scan.
- 2c. To answer pain questionnaire before first CT perfusion scan.
- 2d. To return within three weeks to three months after decompression treatment for another CT perfusion scan and complete the second pain questionnaire.
- 3a. Autoimmune pancreatitis, age 18 to 99 years either with diffuse or focal swelling of the pancreas confirmed by CT, MRI, or EUS or
- 3b. Irregular narrowing of the pancreatic duct on ERCP and either elevated serum immunoglobulin G4 (IgG4), or histological confirmation.
Who cannot join
- 1a. 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:
- 4. Pregnant.
Show all 10Show fewer
- 5. Prior iodine contrast reactions.
- 6. Iodine allergy.
- 7. Decreased kidney function being a serum creatinine greater than 1.5mg/dl.
- 8. Any contraindication to having a CT scan with iodine contrast.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CT Perfusion of Pancreatic Cancer and Chronic Pancreatitis: Feasibility Study
- 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.
- 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).
- Pancreatic CT perfusion parameters can be calculated using surrogate scan data sets at specific time points to replace the continuous scanning.
- Being tested
- Mayo Interactive Breath Hold Monitor
- Keywords
- Inflammation, Pancreas, Chronic pancreatitis, Alcoholic pancreatitis, Carcinoma, pancreatic ductal, Pancreatic neoplasms
- Medical subject headings
- Pancreatitis, Chronic, Autoimmune Pancreatitis, Inflammation, Pancreatitis, Alcoholic, Carcinoma, Pancreatic Ductal, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mayo Interactive Breath Hold MonitorDevice
Biofeedback device
| Study group | Role | What they receive |
|---|---|---|
| 1 | Suspected pancreatic ductal adenocarcinoma. Receives: Device: Mayo Interactive Breath Hold Monitor | |
| 2 | Chronic pancreatitis and slated for decompression treatment. Receives: Device: Mayo Interactive Breath Hold Monitor | |
| 3 | Autoimmune pancreatitis. Receives: Device: Mayo Interactive Breath Hold Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three weeks to three months for chronic pancreatitis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2008 (estimated)
- Study startApr 2006
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naoki Takahashi, Mayo Clinic
- Investigators
- Naoki Takahashi, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00588367
- Sponsor's protocol ID
- 360-06
- Status last verified
- Apr 2015
- First submitted
- 24 Dec 2007
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Perfusion of Pancreatic Cancer and Chronic Pancreatitis: Feasibility Study
- ClinicalTrials.gov ID
- NCT00588367
- Acronym / sponsor ID
- 360-06
- Keywords
- Inflammation, Pancreas, Chronic pancreatitis, Alcoholic pancreatitis, Carcinoma, pancreatic ductal, Pancreatic neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 8 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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).
- Pancreatic CT perfusion parameters can be calculated using surrogate scan data sets at specific time points to replace the continuous scanning.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Mayo Interactive Breath Hold MonitorSuspected pancreatic ductal adenocarcinoma. |
| 2 | – | Device: Mayo Interactive Breath Hold MonitorChronic pancreatitis and slated for decompression treatment. |
| 3 | – | Device: Mayo Interactive Breath Hold MonitorAutoimmune pancreatitis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mayo Clinic patients being seen in Pancreas Clinic.
Key inclusion criteria (7 listed)
- 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).
- 2b. To undergo endoscopic or surgical decompression with 0 to 10 days of first study visit CT perfusion scan.
- 2c. To answer pain questionnaire before first CT perfusion scan.
- 2d. To return within three weeks to three months after decompression treatment for another CT perfusion scan and complete the second pain questionnaire.
Key exclusion criteria (10 listed)
- 1a. 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 .
- 4. Pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mayo Interactive Breath Hold MonitorBiofeedback device | Device | 1, 2, 3 |
Primary outcome
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.
Time frame: Three weeks to three months for chronic pancreatitis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naoki Takahashi, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Ductal Adenocarcinoma and Chronic Pancreatitis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Three weeks to three months for chronic pancreatitis.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2015.