Positron Emission Tomography-computed Tomography (PET-CT) for Main & Branch Intraductal Papillary Mucinous Neoplasm

July 11, 2016 updated by: Christian M. Schmidt, Indiana University

PET-CT for Intraductal Papillary Mucinous Neoplasm (IPMN)

The purpose of the study is to prove the hypothesis that pancreas PET-CT can differentiate duct involved IPMN with malignancy from duct involved non-malignant IPMN.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Duct involved intraductal papillary mucinous neoplasm is associated with a 35-70% (particularly involving the main duct) incidence of malignancy. Current guidelines recommend pancreatic resection for fit patients with main or branch duct involved IPMN. Pancreatic resection can be associated with morbidity and mortality. Reliable tests or biomarkers accurately differentiating non-malignant from malignant duct involved IPMN are non-existent. Test or biomarkers differentiating duct involved from duct uninvolved IPMN are also inaccurate. Patients with suspected duct IPMN with symptoms have a higher chance of associated malignancy. These findings are not specific for malignant IPMN so, if relied on, they would results in missed malignancies as well as potentially unnecessary operations in a significant percentage of patients. PET scanning has been studied retrospectively and purported to be a highly reliable indicator og high grade dysplasia and/or invasive cancer in patients with IPMN. Thus, PET could represent a future standard of care by some authorities in the work-up of patients with IPMN. This proposal seeks to prove the hypothesis that pancreas PET-CT can differentiate duct involved IPMN with malignancy from duct involved IPMN without malignancy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects are selected from group of patients in whom IPMN is suspected as they are seen in the clinic for consultation with the surgeon regarding their surgical procedure.

Description

Inclusion Criteria:

  • Patients will be eligible for the study if they have a clinical and/or cytopathologic diagnosis of IPMN (primary or recurrent) with suspected main or branch duct involvement.
  • A clinical diagnosis of IPMN with main duct involvement will be determined by the surgeon caring for the patient. Main duct involvement may be suspected where there is a significant radiographic character change (cystic dilation) in the main pancreatic duct (independent of ductal diameter), a significant "step-up" in main duct diameter (2-3 fold) or a significant segmental or diffuse dilation of the main pancreatic duct (> or equal to 4mm) as defined by CT, MRCP, EUS or ERCP.
  • All patients with a diagnosis (pathologic) or presumed diagnosis (based upon clinical presentation) of IPMN and who are to undergo surgical treatment are eligible for the study. This may include patients who have already undergone IPMN surgery in the past and who are expected to undergo a second IPMN surgery.
  • Patients with unrecoverable renal function on dialysis are eligible to undergo this study.
  • Female patients of child-bearing age must have a negative urine or serum pregnancy test prior to enrollment.
  • Subjects must have medical insurance or Medicare willing to pay for the cost of this PET-CT procedure or the CT portion of the procedure.

Exclusion Criteria:

  • Patients who despite suspected duct involved IPMN are not fit surgical candidates and thus will not undergo resection of their IPMN.
  • Patients with uncontrolled serum glucose will not be eligible for the study due to the unreliability of PET in these patients. Diabetic patients are eligible as long as their glucose is reasonably controlled (as determined by the nuclear medicine radiologists). The Department of Radiology has a Standard Operating Procedure in place for the management of these patients which will be followed in this protocol.
  • Pediatric patients are excluded from this study since IPMN is a diagnosis present in adult patients.
  • Female patients who are pregnant or who are currently breastfeeding.
  • Patients with allergy to IV contrast have a relative contraindication to the study. Some of these patients at the discretion of the investigator may undergo a standard protocol of pre-IV contrast steroids to manage their allergic response. The Department of Radiology has guidelines that will be followed in this protocol for patients who have experienced an allergic reaction to IV contrast.
  • Patients with renal insufficiency (creatinine > or equal to 2.0) have a relative contraindication to the study. At the investigator's discretion these patients may be enrolled and undergo PET-CT without IV contrast.
  • Patients without insurance or Medicare coverage or patients with insurance/Medicare coverage but insurer is unwilling to pay for the cost of the PET-CT procedure or the CT portion of the procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Pancreas PET-CT can differentiate duct involved IPMN with malignancy from duct involved IPMN without malignancy.
Time Frame: Six months
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indiana University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christian M Schmidt, MD, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0810-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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