In short
Clinical trials investigating GRAPHITE are studying its use in lung imaging after pulmonary embolism. These trials aim to evaluate regional lung function and measure how well blood flow is restored in the lungs. The main target population is adults with pulmonary embolism.
Key points
- GRAPHITE is being studied in one authorised Phase 1 clinical trial for people with pulmonary embolism. The trial uses V/Q PET/CT imaging to assess regional lung function after the condition. Researchers are measuring the pulmonary vascular obstruction index, which shows how much of the lung blood flow is blocked. The study is interventional and plans to include 32 participants. The trial focuses on how lung perfusion, or blood flow, changes after treatment-related assessment.
Trial overview
The clinical trial with GRAPHITE is studying lung imaging after pulmonary embolism, which is a blockage in the lung blood vessels. The study is looking at regional lung function, meaning how different parts of the lungs work, especially blood flow in the lung.
This trial is titled “Ventilation/Perfusion PET/CT with Galligas and 68Ga-MAA for regional lung function assessment after pulmonary embolism.” The brief goal is to assess the impact of PR on regional perfusion lung function with lung V/Q PET/CT imaging.
Who can participate
The target population in this study is people with pulmonary embolism. The trial is listed with an enrollment of 32 participants, so it is a small study.
The data provided does not list detailed inclusion or exclusion criteria, so we only know the main condition being studied.
What is being measured
The main endpoint is the pulmonary vascular obstruction index (PVOI), which is measured as a percentage of whole lung volume on V/Q PET/CT imaging. An endpoint is the main result researchers want to measure in a trial.
This endpoint helps researchers understand how much of the lung blood vessel area is blocked after pulmonary embolism. The study is focused on regional perfusion, which means blood flow in different parts of the lungs.
Trial design and phase
This is an interventional trial, which means researchers are actively using study-related imaging agents in the research process. The trial phase is Phase 1.
The status of the study is Authorised. This means the study has been approved to proceed.
Imaging method used in the study
The study uses V/Q PET/CT, which combines ventilation imaging and perfusion imaging with PET/CT scanning. Ventilation means air flow in the lungs, and perfusion means blood flow.
The trial intervention list includes PULMOTEC, described as a graphite crucible for preparing Technegas for inhalation, and Pulmocis 2 mg, a radiopharmaceutical preparation. The source data does not provide more detail about how these are compared or used beyond the imaging study description.
Study status and size
The trial is currently listed as Authorised and plans to include 32 participants. This makes it a small early-phase study rather than a large confirmatory trial.
Because only one trial is provided, the evidence here is limited to this specific study design, condition, and endpoint.