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

NCT00988416 | Completed DMC

• 1 other identifier: 0810-11
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intraductal Papillary Mucinous Neoplasm

Keywords

IPMN

Outcome Measures

Primary Outcomes (1)

• Pancreas PET-CT can differentiate duct involved IPMN with malignancy from duct involved IPMN without malignancy.

  Six months

Interventions

PET-CT PROCEDURE

Pancreas Protocol PET-CT

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

Location

Study Officials

• Christian M Schmidt, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery, Biochemistry and Molecular Biology

Study Record Dates

• First Submitted: September 29, 2009
• First Posted: October 2, 2009
• Study Start: September 1, 2009
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

US (1)