CholecystitisNCT00590395
FDG-PET/CT in the Evaluation of Patients With Suspected Cholecystitis
A study testing 18FDG (an FDA-approved radiopharmaceutical) in people with Cholecystitis, run by Alan D. Waxman, M.D. at 1 site in United States.
Trial summary
This is a pilot study to investigate the ability of fluorodeoxyglucose-positron emission tomography (FDG-PET) and Positron emission tomography-computed tomography (PET/CT) as a direct method of detecting infection and/or inflammation of the gallbladder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystitis
- What is being tested?
- 18FDG (an FDA-approved radiopharmaceutical)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jul 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- known or high suspicion of cholecystitis
- highly likely to undergo cholecystectomy
- positive HIDA study
- age >18 years old
- provide written informed consent
Who cannot join
- highly unlikely to proceed to surgery or biopsy
- received an investigational drug within the past 30 days
- pregnant or lactating
- decline to provide written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center, S. Mark Taper Foundation Imaging Center
Los Angeles, California, 90048
About this study
Official title: The Utility of FDG-PET and PET/CT in the Evaluation of Patients With Suspected Cholecystitis
This is a pilot study to investigate the ability of fluorodeoxyglucose-positron emission tomography (FDG-PET) and Positron emission tomography-computed tomography (PET/CT) as a direct method of detecting infection and/or inflammation of the gallbladder.
Read the detailed description
Hepatobiliary iminodiacetic acid (HIDA) scan scintigraphy is a nuclear medicine scan used to evaluate patients suspected of having acute cholecystitis (infection/inflammation of the gallbladder). Because it is an indirect test that looks for obstruction of the cystic duct structure, there are many causes for a false-positive HIDA study. There is a need for a more sensitive and specific test that can accurately assess gallbladder infection and/or inflammation.
The purpose of this study is to determine the effectiveness of fluorodeoxyglucose (FDG) as a direct means of detecting patients with acute cholecystitis. FDG is an imaging agent that has previously been shown to accumulate in areas of infection and/or inflammation. The location and intensity of FDG accumulation in the body can be detected with a camera system called a "positron emission tomography" (PET) camera. In theory, this test should be effective in detecting acute infection and/or inflammation of the gallbladder.
Consenting participants will receive injection of FDG one hour prior to the FDG-PET/CT examination. The participant will then be imaged using a PET/CT machine, which is a special camera system that is capable of performing both a PET and CT scan at the same time. A CT scan is an anatomical imaging test and, for this research study, will mainly be used to localize the area of 18FDG accumulation recorded by the PET scan. The examination will take approximately one hour.
- Conditions
- Cholecystitis
- Being tested
- 18FDG (an FDA-approved radiopharmaceutical)
- Keywords
- Cholecystitis, FDG PET/CT, HIDA scan
- Medical subject headings
- Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18FDG (an FDA-approved radiopharmaceutical)Drug
Also called 2-deoxy-2-[18F] fluoro-D-glucose (18FDG)
Route: Intravenous, Dosage: 5-10mCi, frequency: Single Administration
| Study group | Role | What they receive |
|---|---|---|
| FDG-PET/CT to determine Cholecystitis | Experimental | 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. Receives: Drug: 18FDG (an FDA-approved radiopharmaceutical) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of FDG PET/CT and Tc99mHIDA in the Evaluation of Subjects Suspected of Cholecystitis
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.
Measured: 1-2 days through the post operative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startJul 2007
- Primary completionJan 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CholecystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alan D. Waxman, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alan D. Waxman, M.D., Cedars-Sinai Medical Center
- Investigators
- Alan D. Waxman, M.D., Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590395
- Sponsor's protocol ID
- CSMC IRB Pro00007311
- Other IDs
- CSMC216788
- Status last verified
- Dec 2019
- First submitted
- 26 Dec 2007
- Last updated
- 10 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of FDG-PET and PET/CT in the Evaluation of Patients With Suspected Cholecystitis
- ClinicalTrials.gov ID
- NCT00590395
- Acronym / sponsor ID
- CSMC IRB Pro00007311
- Conditions
- Cholecystitis
- Keywords
- Cholecystitis, FDG PET/CT, HIDA scan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Alan D. Waxman, M.D.University, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 10 Jan 2008 (estimated)
- Results
- Posted 17 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study to investigate the ability of fluorodeoxyglucose-positron emission tomography (FDG-PET) and Positron emission tomography-computed tomography (PET/CT) as a direct method of detecting infection and/or inflammation of the gallbladder.
Detailed description
Hepatobiliary iminodiacetic acid (HIDA) scan scintigraphy is a nuclear medicine scan used to evaluate patients suspected of having acute cholecystitis (infection/inflammation of the gallbladder). Because it is an indirect test that looks for obstruction of the cystic duct structure, there are many causes for a false-positive HIDA study. There is a need for a more sensitive and specific test that can accurately assess gallbladder infection and/or inflammation.
The purpose of this study is to determine the effectiveness of fluorodeoxyglucose (FDG) as a direct means of detecting patients with acute cholecystitis. FDG is an imaging agent that has previously been shown to accumulate in areas of infection and/or inflammation. The location and intensity of FDG accumulation in the body can be detected with a camera system called a "positron emission tomography" (PET) camera. In theory, this test should be effective in detecting acute infection and/or inflammation of the gallbladder.
Consenting participants will receive injection of FDG one hour prior to the FDG-PET/CT examination. The participant will then be imaged using a PET/CT machine, which is a special camera system that is capable of performing both a PET and CT scan at the same time. A CT scan is an anatomical imaging test and, for this research study, will mainly be used to localize the area of 18FDG accumulation recorded by the PET scan. The examination will take approximately one hour.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FDG-PET/CT to determine Cholecystitis | Experimental | Drug: 18FDG (an FDA-approved radiopharmaceutical)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- known or high suspicion of cholecystitis
- highly likely to undergo cholecystectomy
- positive HIDA study
- age >18 years old
- provide written informed consent
Key exclusion criteria (4 listed)
- highly unlikely to proceed to surgery or biopsy
- received an investigational drug within the past 30 days
- pregnant or lactating
- decline to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18FDG (an FDA-approved radiopharmaceutical)Also: 2-deoxy-2-[18F] fluoro-D-glucose (18FDG)Route: Intravenous, Dosage: 5-10mCi, frequency: Single Administration | Drug | FDG-PET/CT to determine Cholecystitis |
Primary outcome
Sensitivity and Specificity of FDG PET/CT and Tc99mHIDA in the Evaluation of Subjects Suspected of Cholecystitis
Time frame: 1-2 days through the post operative period
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan D. Waxman, M.D. principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18FDG (an FDA-approved radiopharmaceutical) in people with Cholecystitis, run by Alan D. Waxman, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of FDG PET/CT and Tc99mHIDA in the Evaluation of Subjects Suspected of Cholecystitis (time frame: 1-2 days through the post operative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2019.