Trial Outcomes & Findings for Use of PET Imaging to Distinguish Malignant From Benign IPMN (NCT NCT01104116)

Last Updated: 2016-09-15

Results Overview

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 positive, with focal FDG uptake corresponding to pancreatic lesion.

Recruitment status

TERMINATED

Study phase

Target enrollment

1 participants

Primary outcome timeframe

1 month

Results posted on

2016-09-15

Participant Flow

The principal investigator has left the institution. Data will not be analyzed. Only the demographic information on 1 enrolled subject is available.

Participant milestones

Participant milestones
Measure	PET/CT Imaging Surgical patients will undergo \[18F\]-FDG PET/CT imaging \[18F\]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of PET Imaging to Distinguish Malignant From Benign IPMN

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PET/CT Imaging n=1 Participants Surgical patients will undergo \[18F\]-FDG PET/CT imaging \[18F\]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	1 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	1 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: 1 month

Population: The principal investigator has left the institution. Data will not be analyzed. Only the demographic information on 1 enrolled subject is available.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 month

Population: The principal investigator has left the institution. Data will not be analyzed. Only the demographic information on 1 enrolled subject is available.

The secondary outcome that we are interested in studying is the benefit of PET scan as compared to other imaging modalities, such as CT, MRI, and EUS. Thus, Patients will also have CT, MRI, and EUS imaging. We will look at how size, location, and branch of the IPMN lesion on PET compare to these other imaging modalities. The location, size, and pathology results of the actual surgical specimen will serve as the gold standard.

Outcome measures

Outcome data not reported

Adverse Events

PET/CT Imaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

CU PRS Administrator

Columbia University

Phone: 212-342-1643

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place