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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: Clinical Trial NA study, sponsored by Columbia University.

NCT01104116 is a NA study that was terminated before completion, run by Columbia University. The registered enrollment target is 1 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The primary outcome will be to determine the positive and negative predictive values of \[18F\]-FDG PET imaging for identifying malignant IPMN lesions in patients who are to undergo surgical resection. We will determine the mean SUV that would provide optimal positive predictive value for malignant IPMN. IPMN lesions will be classified categorically as benign (adenoma or borderline ) or malignant (in situ or invasive carcinoma) and PET imaging will be classified categorically as negative or posi

Interventions

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

Trial Details

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

958 total trials

Why NCT01104116 stopped before completion

NCT01104116 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

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

NCT01104116 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01104116's enrollment target sits among peer trials

1 2001st of 2000 the lowest of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01104116, the US trial registry maintained by the National Library of Medicine. NCT01104116 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.