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