Evaluation of [68Ga]Ga-DFO-B PET/CT Imaging for Pulmonary Aspergillosis Using Deferoxamine Mesilate and Gallium-68 Chloride in Adult Patients

The primary objective of the study is to demonstrate the feasibility of **[68Ga]Ga-DFO-B PET/CT** for the visualization of **pulmonary aspergillosis**. This is clinically relevant as it aims to provide a novel imaging technique for detecting Aspergillus infections in the lungs, potentially improving diagnostic accuracy and patient management.

Secondary objectives include investigating the influence of potential confounding factors on the in vivo biodistribution of **[68Ga]Ga-DFO-B**. Understanding these factors is crucial for optimizing the imaging process and ensuring reliable interpretation of PET/CT scans in clinical settings.

The clinical trial focuses on individuals with **pulmonary aspergillosis**, aiming to assess the feasibility of [68Ga]Ga-DFO-B PET/CT for visualizing Aspergillus infections in the lungs. The study population includes both male and female participants, aged 18 years and older, with suspected chronic pulmonary aspergillosis or allergic bronchopulmonary aspergillosis (ABPA). Participants are selected based on their age and the presence of the specified medical condition, ensuring no significant interference with their standard care and follow-up. The trial does not involve a vulnerable population. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet or physical activity.

The clinical trial is designed to evaluate the feasibility of **[68Ga]Ga-DFO-B PET/CT** for visualizing pulmonary aspergillosis. This is a Phase 4, randomized, double-blind, controlled trial. The trial is expected to commence on February 1, 2024, and conclude by February 1, 2025. The study will involve the administration of a standard dose of 100 MBq **[68Ga]Ga-DFO-B** to 10 patients diagnosed with pulmonary aspergillosis. The primary endpoint is to assess the quantitative uptake and target-to-background ratios of **[68Ga]Ga-DFO-B** in suspected aspergillus lesions. Secondary endpoints include evaluating uptake patterns in different forms of pulmonary aspergillosis and comparing these patterns with human iron status and various blood cell counts.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age (at least 18 years) and suspected chronic pulmonary aspergillosis or allergic bronchopulmonary aspergillosis (ABPA). The trial will not interfere significantly with standard care and follow-up. Following the screening, participants will attend follow-up visits for the administration of the investigational product and subsequent imaging procedures. The end-of-study visit will involve final assessments to evaluate the outcomes of the intervention.

The expected duration of participant involvement is approximately one year, aligning with the overall trial duration. Conditions that may lead to early termination from the study include adverse reactions to the investigational product or any significant deviation from the protocol that could impact the safety or scientific integrity of the trial. The trial will adhere to rigorous ethical standards and regulatory requirements to ensure the safety and well-being of all participants.

The clinical trial involves the use of **Deferoxamine Mesilate**, a chemical compound with the active substance name **DEFEROXAMINE MESILATE**. This experimental medication is administered in the form of a pharmaceutical preparation identified by the code PHF00231MIG. The administration route is **intravenous**, with a maximum daily dose of 100 micrograms. The total dose is also capped at 100 micrograms, and the treatment period is limited to one day. The compound is chemically synthesized and is not a pediatric formulation. In this study, **Deferoxamine Mesilate** is combined with **Gallium-68** to form the complex 68Ga-DFO, which is used for imaging purposes.

**Gallium (68Ga) Chloride** is another key component of the trial, serving as a radiopharmaceutical precursor in solution form. The active substance, **GALLIUM (68GA) CHLORIDE**, is also administered intravenously. The maximum daily and total dose for this compound is 110 megabecquerels, with the treatment period similarly restricted to one day. This compound is chemically derived and is not intended for pediatric use. In the context of the trial, **Gallium (68Ga) Chloride** is combined with **Deferoxamine** to form the imaging agent 68Ga-DFO, which is utilized in PET/CT scans to visualize pulmonary Aspergillus infections.

No non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatments, are specified in this study. The trial focuses on the feasibility of using the 68Ga-DFO complex for imaging purposes. Participant compliance with the dosing schedule is monitored to ensure adherence to the specified administration guidelines.

Efficacy in the clinical trial titled "iMagIng pulmonaRy Aspergillosis using Gallium-68-dEferoxamine (MIRAGE)" will be assessed using both primary and secondary endpoints. The primary endpoint focuses on the quantitative uptake and target-to-background ratios of **[68Ga]Ga-DFO-B** in suspected aspergillus lesions in patients with pulmonary aspergillosis. This will provide a direct measure of the tracer's ability to visualize the infection.

Secondary endpoints will include the evaluation of **[68Ga]Ga-DFO-B** uptake patterns in different forms of pulmonary aspergillosis, as well as in patients with and without co-infections. Additionally, the study will compare **[68Ga]Ga-DFO-B** uptake patterns to human iron status indicators such as serum iron, transferrin, transferrin saturation, and ferritin. The assessment will also consider the cell-bound and free fraction of **[68Ga]Ga-DFO-B**, and these parameters will be compared to the number of neutrophils, eosinophils, monocytes, and lymphocytes.