Assessment of 18F-Fluoromisonidazole PET Hypoxia Imaging in Idiopathic Pulmonary Fibrosis: A Non-Randomized Proof-of-Concept Study

The primary objective of this study is to evaluate the value of **18F-Fluoromisonidazole (18F-FMISO) positron emission tomography** hypoxia imaging in patients with **idiopathic pulmonary fibrosis**. This investigation aims to determine the potential of 18F-FMISO PET imaging as a diagnostic tool to assess hypoxic regions within the lungs of affected individuals. Understanding hypoxia in idiopathic pulmonary fibrosis is clinically relevant as it may provide insights into disease progression and potential therapeutic targets.

The clinical trial involves participants diagnosed with **idiopathic pulmonary fibrosis**. The study population includes both male and female subjects, with an age range corresponding to categories 3 and 4, which typically represent adults and older adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet, physical activity, or habits. Additionally, key inclusion or exclusion criteria have not been disclosed. The selection process for the trial population remains unspecified.

The clinical trial is a **Phase 3** study designed to evaluate the utility of **18F-Fluoromisonidazole (18F-FMISO)** positron emission tomography hypoxia imaging in patients with **idiopathic pulmonary fibrosis** compared to healthy subjects. This is a non-randomized, proof-of-concept study. The trial is set to commence recruitment on November 1, 2024, and is expected to conclude by May 20, 2026. Participants will be involved in the study for a duration that aligns with the trial's timeline, with specific visit schedules outlined to ensure comprehensive data collection and participant monitoring.

The study will begin with an inclusion visit, where potential participants will undergo a screening process to determine eligibility based on predefined criteria. This visit will include a detailed medical history review, physical examination, and necessary laboratory tests. Following successful inclusion, participants will attend a series of follow-up visits. These visits are structured to monitor the participants' health status, assess the imaging outcomes, and ensure adherence to the study protocol. The frequency and number of follow-up visits will be determined by the study's specific requirements and the participants' health status.

The end-of-study visit will mark the conclusion of a participant's involvement in the trial. During this visit, final assessments will be conducted to evaluate the study's primary and secondary endpoints. Participants may be withdrawn from the study prematurely if they experience adverse events, fail to comply with the study protocol, or choose to withdraw consent. The study's design and procedures are meticulously planned to ensure the collection of high-quality data while prioritizing participant safety and well-being.

The clinical trial documentation does not provide specific details regarding the **experimental medication** used in the study. Information such as the name, pharmaceutical form, dosage, route, and frequency of administration is not available. Additionally, there is no data on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.

Details about any **non-experimental treatments** used in the study, such as standard-of-care therapy, placebo, or comparator treatment, are not provided. There is no information on additional relevant aspects of drug administration, dosing schedules, or participant compliance monitoring. The absence of this data limits the ability to describe the treatments comprehensively.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on November 1, 2024, with an estimated completion date of May 20, 2026. The efficacy assessment will be conducted through a series of pre-defined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the available data. The trial will follow a structured protocol to ensure the collection and analysis of efficacy data is consistent and reliable throughout the study duration. The trial's design and execution will adhere to the rigorous standards expected in a Phase 3 clinical trial, ensuring that the results are scientifically valid and applicable to the broader patient population.