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NCT03824535 · ClinicalTrials.gov registry record · Phase 2
18F-FSPG PET/CT in Diagnosing Early Lung Cancer in Patients With Lung Nodules
A Phase 2 study of Cigarette Smoker and Multiple Pulmonary Nodules, sponsored by Andrei Iagaru.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT03824535: Completed Phase 2 study of Cigarette Smoker and Multiple Pulmonary Nodules, sponsored by Andrei Iagaru.
NCT03824535 is a Phase 2 study of Cigarette Smoker and Multiple Pulmonary Nodules that has completed, run by Andrei Iagaru. The registered enrollment target is 15 participants, below the 913-participant average among 5 other Cigarette Smoker trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03824535, a Phase 2 study of Cigarette Smoker and Multiple Pulmonary Nodules, has completed, sponsored by Andrei Iagaru.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well 18F-FSPG positron emission tomography (PET)/computed tomography (CT) work in diagnosing early lung cancer in patients with indeterminate lung nodules. PET imaging with an imaging agent called 18F-FDG is often used in combination with a PET/CT scanner to evaluate cancers. Giving 18F-FSPG before a PET/CT scan may work better in helping researchers diagnose early lung cancer in patients with lung nodules.
Primary Outcome
The diagnostic performance of ultrasonography and capnography in detecting malignant lung nodules was assessed using sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy. Sensitivity and specificity were calculated to determine the ability to correctly identify malignant and non-malignant nodules, respectively. Results were compared to a predefined threshold of 75%, with all percentages reported as proportions of the total number of nodules ana
Conditions Studied
Interventions
- DRUG Fludeoxyglucose F-18
- DIAGNOSTIC_TEST Computed Tomography
- DRUG Fluorine F 18 L-glutamate Derivative BAY94-9392
- DIAGNOSTIC_TEST Positron Emission Tomography (PET/CT)
Study Locations (1)
California
- Stanford Cancer Institute Palo Alto - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-02-04 |
| Est. Completion | 2021-07-30 |
| Phase | Phase 2 |
What the finished NCT03824535 record still lists
NCT03824535 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 913-participant average among 5 other Cigarette Smoker trials with a reported enrollment target (98% lower).
The record links to 5 conditions, with Cigarette Smoker appearing as the primary indexed condition, and to 4 interventions - of which Fludeoxyglucose F-18 is the first listed.
NCT03824535 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03824535 about?
NCT03824535 is a clinical study titled "18F-FSPG PET/CT in Diagnosing Early Lung Cancer in Patients With Lung Nodules". This phase II trial studies how well 18F-FSPG positron emission tomography (PET)/computed tomography (CT) work in diagnosing early lung cancer in patients with indeterminate lung nodules. PET imaging with an imaging agent called 18F-FDG is often used in combination with a PET/CT scanner to evaluate ...
What is the current status of trial NCT03824535?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2019-02-04. Estimated completion is 2021-07-30.
What conditions does trial NCT03824535 study?
This clinical trial studies the following conditions: Cigarette Smoker, Multiple Pulmonary Nodules, Pulmonary Nodule, Current Smoker, Former Smoker.
What interventions are being tested in trial NCT03824535?
The interventions under investigation include: Fludeoxyglucose F-18 (DRUG), Computed Tomography (DIAGNOSTIC_TEST), Fluorine F 18 L-glutamate Derivative BAY94-9392 (DRUG), Positron Emission Tomography (PET/CT) (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03824535?
This trial is sponsored by Andrei Iagaru, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03824535 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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