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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Indiana University
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00988416
First received: September 29, 2009
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Intraductal Papillary Mucinous Neoplasm
Procedure: PET-CT

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: PET-CT for Intraductal Papillary Mucinous Neoplasm (IPMN)

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Pancreas PET-CT can differentiate duct involved IPMN with malignancy from duct involved IPMN without malignancy. [ Time Frame: Six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: September 2009
Estimated Study Completion Date: September 2021
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: PET-CT
    Pancreas Protocol PET-CT
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00988416

Contacts
Contact: Christian M Schmidt, MD 317-278-8349 maxschmi@iupui.edu
Contact: Sarah Dutkevitch, RN 317-274-5495 sdutkevi@iupui.edu

Locations
United States, Indiana
Indiana University Medical Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Christian Schmidt, MD    317-278-8349    maxschmi@iupui.edu   
Principal Investigator: Christian M Schmidt, MD         
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Christian M Schmidt, MD Indiana University
  More Information

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00988416     History of Changes
Other Study ID Numbers: 0810-11
Study First Received: September 29, 2009
Last Updated: July 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
IPMN

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014