Diagnostic Self EvaluationNCT05458089
18F-FDG PET/CT in the Diagnosis of Tuberculous Pericarditis
An observational study of Diagnostic Self Evaluation, run by Wuxi No. 4 People's Hospital.
Trial summary
A total of 11 patients confirmed with tuberculous pericarditis were enrolled in this study to analyze the diagnostic value of 18F-FDG PET/CT for tuberculous pericarditis. Read more about this study
- Who is it for?
- Ages 48 to 81 years
- Conditions the study is for
- Diagnostic Self Evaluation
- What is being tested?
- 18F-FDG
- Type of treatment
- Injection or infusion
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 48 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 11 patients confirmed with tuberculous pericarditis were enrolled in this study.
Who may be able to join
- patients confirmed as tuberculous pericarditis through follow-up.
Who cannot join
- patients confirmed as other pericarditis through follow-up.
About this study
A total of 11 patients confirmed with tuberculous pericarditis were enrolled in this study to analyze the diagnostic value of 18F-FDG PET/CT for tuberculous pericarditis.
Read the detailed description
A total of 11 patients with tuberculous pericarditis, who underwent 18F-FDG PET/CT from January 2015 to February 2022 in the affiliated hospital of Jiangnan university were retrospectively reviewed in this study to analyze the diagnostic value of 18F-FDG PET/CT in tuberculous pericarditis.
- Conditions
- Diagnostic Self Evaluation
- Being tested
- 18F-FDG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDGDiagnostic test
18F-FDG intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| tuberculous pericarditis with 18F-FDG uptake | patients confirmed with tuberculous pericarditis presenting 18F-FDG uptake Receives: Diagnostic Test: 18F-FDG | |
| tuberculous pericarditis without 18F-FDG uptake | patients confirmed with tuberculous pericarditis presenting no 18F-FDG uptake Receives: Diagnostic Test: 18F-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
the diagnostic sensitivity of 18F-FDG PET/CT for tuberculous pericarditis
the diagnostic sensitivity of 18F-FDG PET/CT for tuberculous pericarditis
Measured: 01,2015-02,2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start1 Jan 2015
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnostic Self EvaluationStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuxi No. 4 People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunjing Yu, Wuxi No. 4 People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458089
- Sponsor's protocol ID
- Wuxi4PH-2022-01
- Status last verified
- Jul 2022
- First submitted
- 11 Jul 2022
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-FDG PET/CT in the Diagnosis of Tuberculous Pericarditis
- ClinicalTrials.gov ID
- NCT05458089
- Acronym / sponsor ID
- Wuxi4PH-2022-01
- Conditions
- Diagnostic Self Evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Wuxi No. 4 People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A total of 11 patients confirmed with tuberculous pericarditis were enrolled in this study to analyze the diagnostic value of 18F-FDG PET/CT for tuberculous pericarditis.
Detailed description
A total of 11 patients with tuberculous pericarditis, who underwent 18F-FDG PET/CT from January 2015 to February 2022 in the affiliated hospital of Jiangnan university were retrospectively reviewed in this study to analyze the diagnostic value of 18F-FDG PET/CT in tuberculous pericarditis.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tuberculous pericarditis with 18F-FDG uptake | – | Diagnostic Test: 18F-FDGpatients confirmed with tuberculous pericarditis presenting 18F-FDG uptake |
| tuberculous pericarditis without 18F-FDG uptake | – | Diagnostic Test: 18F-FDGpatients confirmed with tuberculous pericarditis presenting no 18F-FDG uptake |
Who may qualify
- Ages
- 48 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 11 patients confirmed with tuberculous pericarditis were enrolled in this study.
Key inclusion criteria (1 listed)
- patients confirmed as tuberculous pericarditis through follow-up.
Key exclusion criteria (1 listed)
- patients confirmed as other pericarditis through follow-up.
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 |
|---|---|---|
| 18F-FDG18F-FDG intravenous injection | Diagnostic test | tuberculous pericarditis with 18F-FDG uptake, tuberculous pericarditis without 18F-FDG uptake |
Primary outcome
the diagnostic sensitivity of 18F-FDG PET/CT for tuberculous pericarditis
Time frame: 01,2015-02,2022
the diagnostic sensitivity of 18F-FDG PET/CT for tuberculous pericarditis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnostic Self Evaluation, run by Wuxi No. 4 People's Hospital.
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 1 inclusion and 1 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 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the diagnostic sensitivity of 18F-FDG PET/CT for tuberculous pericarditis (time frame: 01,2015-02,2022). 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 14 Jul 2022.