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NCT01104116 · ClinicalTrials.gov registry record · NA

Use of PET Imaging to Distinguish Malignant From Benign IPMN

A NA study, sponsored by Columbia University.

Terminated
Registry status
NA
Development phase
1
Enrollment target

NCT01104116 is a NA study that was terminated before completion, run by Columbia University. The registered enrollment target is 1 participants.

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The verdict

NCT01104116, a NA study, was terminated before completion, sponsored by Columbia University.

TERMINATED
Registry status
NA
Development phase
1 participants
Enrollment target

Study Summary

Intraductal papillary mucinous neoplasm (IPMN) is a cystic pancreatic lesion that is a precursor to invasive pancreatic cancer. Differentiating whether an IPMN lesion is benign or malignant is critical, as the prognosis and management differs drastically, varying from surgery to clinical observation. However, despite physicians' attempts to characterize features concerning for malignancy, it is difficult to determine the likelihood of malignancy with conventional imaging techniques, and an accurate and non-invasive test to identify malignant IPMN is needed. Our hypothesis is that positron emission tomography (PET), a three-dimensional imaging that can identify cancer cells through their increased use of sugars, may be a superior test for differentiating between benign and malignant IPMN lesions. The investigators are planning a prospective pilot study of patients with IPMN who are undergoing surgery for their disease. These patients will undergo PET imaging, as well as computed tomography (CT), magnetic resonance imaging (MRI), and endoscopic ultrasound (EUS) as clinically indicated. Samples of tissue removed during surgery will be assessed and will serve as the gold standard for determining whether the lesion is benign or malignant. The investigators will evaluate the positive and negative predictive values of PET imaging for malignancy within IPMN lesions.

Interventions

  • RADIATION [18F]-FDG PET/CT imaging

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2009-09
Est. Completion 2016-03
Phase NA

Sponsor

Columbia University

958 total trials

What the Registry Record Tells You About NCT01104116

The ClinicalTrials.gov registry entry for NCT01104116 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which [18F]-FDG PET/CT imaging is the first listed.

NCT01104116 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01104116 about?

NCT01104116 is a clinical study titled "Use of PET Imaging to Distinguish Malignant From Benign IPMN". Intraductal papillary mucinous neoplasm (IPMN) is a cystic pancreatic lesion that is a precursor to invasive pancreatic cancer. Differentiating whether an IPMN lesion is benign or malignant is critical, as the prognosis and management differs drastically, varying from surgery to clinical observation...

What is the current status of trial NCT01104116?

This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2009-09. Estimated completion is 2016-03.

What interventions are being tested in trial NCT01104116?

The interventions under investigation include: [18F]-FDG PET/CT imaging (RADIATION).

Who is sponsoring clinical trial NCT01104116?

This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.