Clinical Trials Directory

Trials / Completed

CompletedNCT00988416

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

PET-CT for Intraductal Papillary Mucinous Neoplasm (IPMN)

Status
Completed
Phase
Study type
Observational
Enrollment
69 (actual)
Sponsor
Indiana University · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREPET-CTPancreas Protocol PET-CT

Timeline

Start date
2009-09-01
Primary completion
2016-04-01
Completion
2016-04-01
First posted
2009-10-02
Last updated
2016-07-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00988416. Inclusion in this directory is not an endorsement.