Trial Outcomes & Findings for FDG-PET/CT in the Evaluation of Patients With Suspected Cholecystitis (NCT NCT00590395)

Results Overview

Percent of patients identified of having cholecystitis using FDG PET/CT compared to patients identified of having pathological diagnosis of cholecystitis (sensitivity) Percent of patients identified of not having cholecystitis using FDG PET/CT compared to patients identified of not having pathological diagnosis of cholecystitis (specificity) * number of false positives = number of patients incorrectly identified of having cholecystitis using FDG PET/CT compared to a negative pathological diagnosis. * number of false negatives = number of patients incorrectly identified of not having cholecystitis using FDG PET/CT compared to a positive pathological diagnosis. * number of true positives = number of patients correctly identified of having cholecystitis using FDG PET/CT compared to a positive pathological diagnosis. * number of true negatives = number of patients correctly identified of not having cholecystitis using FDG PET/CT compared to a negative pathological diagnosis.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

19 participants

Primary outcome timeframe

1-2 days through the post operative period

Results posted on

2019-12-10

Participant Flow

Participant milestones

Participant milestones
Measure	Patients With Suspected Acute Cholecystitis 19 patients with suspected acute cholecystitis and a positive hepatobiliary iminodiacetic acid (HIDA) will be included in the study. This is purposely a highly selective population which most likely will have surgical proof of the findings. Subjects will receive an FDG (fluorodeoxyglucose) Positron Emission Tomography - Computed Tomography (PET/CT) exam to determine the presence of gallbladder inflammation/infection(cholecystitis). Please note that 18FDG is an FDA approved radiopharmaceutical. 18FDG (an FDA-approved radiopharmaceutical): Route: Intravenous, Dosage: 5-10mCi, frequency: Single Administration
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Suspected Acute Cholecystitis n=19 Participants 19 patients with suspected acute cholecystitis and a positive HIDA will be included in the study. This is purposely a highly selective population which most likely will have surgical proof of the findings. Subjects will receive an FDG PET/CT exam to determine the presence of gallbladder inflammation/infection(cholecystitis). Please note that 18FDG is an FDA approved radiopharmaceutical. 18FDG (an FDA-approved radiopharmaceutical): Route: Intravenous, Dosage: 5-10mCi, frequency: Single Administration
Age, Categorical <=18 years	0 Participants n=19 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=19 Participants
Age, Categorical >=65 years	6 Participants n=19 Participants
Sex: Female, Male Female	7 Participants n=19 Participants
Sex: Female, Male Male	12 Participants n=19 Participants
Region of Enrollment United States	19 participants n=19 Participants

PRIMARY outcome

Timeframe: 1-2 days through the post operative period

Population: All patients

Percent of patients identified of having cholecystitis using FDG PET/CT compared to patients identified of having pathological diagnosis of cholecystitis (sensitivity) Percent of patients identified of not having cholecystitis using FDG PET/CT compared to patients identified of not having pathological diagnosis of cholecystitis (specificity) * number of false positives = number of patients incorrectly identified of having cholecystitis using FDG PET/CT compared to a negative pathological diagnosis. * number of false negatives = number of patients incorrectly identified of not having cholecystitis using FDG PET/CT compared to a positive pathological diagnosis. * number of true positives = number of patients correctly identified of having cholecystitis using FDG PET/CT compared to a positive pathological diagnosis. * number of true negatives = number of patients correctly identified of not having cholecystitis using FDG PET/CT compared to a negative pathological diagnosis.

Outcome measures

Outcome measures
Measure	Suspected Acute Cholecystitis n=19 Participants 19 patients with suspected acute cholecystitis and a positive HIDA will be included in the study. This is purposely a highly selective population which most likely will have surgical proof of the findings. Subjects will receive an FDG PET/CT exam to determine the presence of gallbladder inflammation/infection(cholecystitis). Please note that 18FDG is an FDA approved radiopharmaceutical. 18FDG (an FDA-approved radiopharmaceutical): Route: Intravenous, Dosage: 5-10mCi, frequency: Single Administration
Sensitivity and Specificity of FDG PET/CT and Tc99mHIDA in the Evaluation of Subjects Suspected of Cholecystitis +PET/CT · +Path	9 Participants
Sensitivity and Specificity of FDG PET/CT and Tc99mHIDA in the Evaluation of Subjects Suspected of Cholecystitis +PET/CT · -Path	0 Participants
Sensitivity and Specificity of FDG PET/CT and Tc99mHIDA in the Evaluation of Subjects Suspected of Cholecystitis +PET/CT · N/A Path	1 Participants
Sensitivity and Specificity of FDG PET/CT and Tc99mHIDA in the Evaluation of Subjects Suspected of Cholecystitis -PET/CT · +Path	1 Participants
Sensitivity and Specificity of FDG PET/CT and Tc99mHIDA in the Evaluation of Subjects Suspected of Cholecystitis -PET/CT · -Path	2 Participants
Sensitivity and Specificity of FDG PET/CT and Tc99mHIDA in the Evaluation of Subjects Suspected of Cholecystitis -PET/CT · N/A Path	6 Participants

Adverse Events

Suspected Acute Cholecystitis

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

Alan Waxman, M.D.

Cedars Sinai Medical Center

Phone: 310-423-8000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place