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NCT05452889 · ClinicalTrials.gov registry record · Early Phase 1
PET Image in PAH Patients
A Early Phase 1 study of Pulmonary Arterial Hypertension, sponsored by Stephen Y. Chan.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 71
- Enrollment target
- 1
- Study location
NCT05452889: Recruiting Early Phase 1 study of Pulmonary Arterial Hypertension, sponsored by Stephen Y. Chan.
NCT05452889 is a Early Phase 1 study of Pulmonary Arterial Hypertension that is actively recruiting participants, run by Stephen Y. Chan. The registered enrollment target is 71 participants, below the 461-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05452889, a Early Phase 1 study of Pulmonary Arterial Hypertension, is actively recruiting participants, sponsored by Stephen Y. Chan.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 71 participants
- Enrollment target
- 1
- Study location
Study Summary
Pulmonary arterial hypertension (PAH) is mortal disease affecting the blood vessels of the lung. Despite its morbid prognosis, PAH is often misdiagnosed or ignored, with an average time of 44 months between onset of symptoms to diagnosis and substantial progression of disease severity. Therefore, a pressing need exists to develop non-invasive diagnostic imaging tools, particularly that can detect early disease stages. Efforts have been made to develop such imaging capabilities through platform development of echocardiography, cardiac MRI, chest computed tomography (CT), and positron emission tomography (PET), among others. While some have demonstrated promise, few have shown a precise ability to offer disease quantifications of the diseased lung and vasculature itself, to detect early stages of disease, and to reflect alterations of the lung, vasculature, and right ventricle that reflect the molecular origins of this disease. \[F-18\]FGln has been previously utilized in oncology studies as a non-invasive in vivo imaging biomarker of tumor glutamine flux and metabolism. Our preliminary in vivo pre-clinical rodent studies demonstrated that \[F-18\]FGln demonstrated increased uptake in diseased pulmonary vessels and the right ventricle in a rodent model of PAH. The proposed research study will provide preliminary evidence of the potential to utilize \[F-18\]FGln as a non-invasive imaging biomarker of glutamine flux and metabolism across a range of PAH subjects.
Primary Outcome
Regional \[F-18\] fluoroglutamine (18F-FGN) utilization will be measured as standardized uptake values (SUV) of 18F-FGN in right ventricle wall, left ventricle wall, and perivascular tissue within the lung parenchyma.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST 18F-FGLN PET Imaging
- DRUG (18F)FPGLU
Study Locations (1)
Pennsylvania
- Montefiore Hospital Clinical and Translational Research Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2022-07-11 |
| Est. Completion | 2027-02 |
| Phase | Early Phase 1 |
What NCT05452889 shows while recruiting
NCT05452889 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 461-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Pulmonary Arterial Hypertension appearing as the primary indexed condition, and to 2 interventions - of which 18F-FGLN PET Imaging is the first listed.
NCT05452889 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05452889 about?
NCT05452889 is a clinical study titled "PET Image in PAH Patients". Pulmonary arterial hypertension (PAH) is mortal disease affecting the blood vessels of the lung. Despite its morbid prognosis, PAH is often misdiagnosed or ignored, with an average time of 44 months between onset of symptoms to diagnosis and substantial progression of disease severity. Therefore, a ...
What is the current status of trial NCT05452889?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 71 participants. The study started on 2022-07-11. Estimated completion is 2027-02.
What conditions does trial NCT05452889 study?
This clinical trial studies the following conditions: Pulmonary Arterial Hypertension.
What interventions are being tested in trial NCT05452889?
The interventions under investigation include: 18F-FGLN PET Imaging (DIAGNOSTIC_TEST), (18F)FPGLU (DRUG).
Who is sponsoring clinical trial NCT05452889?
This trial is sponsored by Stephen Y. Chan, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05452889 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05452889's enrollment target sits among peer trials
71 24th of 63 higher than 40 of 63 other Pulmonary Arterial Hypertension trials
participants (enrollment target), bucketed by value
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