Biodistribution Assessment to Optimize Dosage in Cancer Patients Using Long Axial Field of View Scanners for Targeted PET Imaging

The primary objective of the study is to evaluate the **biodistribution** of radiotracers in patients with **cancer** using long axial field of view scanners in order to optimize and potentially reduce the dose required for targeted PET imaging. This is clinically relevant as it aims to enhance the safety and efficacy of PET scans by minimizing radiation exposure while maintaining diagnostic accuracy, which is crucial for patient management and treatment planning in oncology.

The clinical trial involves participants diagnosed with **cancer**. 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. The selection criteria for the trial population, as well as any relevant lifestyle considerations such as diet, physical activity, or habits, have not been disclosed. Key inclusion or exclusion criteria are also not specified by the sponsor.

The clinical trial is designed to evaluate the **biodistribution** of a targeted PET scan in patients with **cancer**. This study is a Phase 3 trial, which is expected to commence recruitment on September 1, 2024, and conclude by September 1, 2026. The trial employs a randomized, double-blind, controlled design to ensure the reliability and validity of the results. Participants will be randomly assigned to either the experimental group or the control group, with neither the participants nor the researchers aware of the group assignments, thus maintaining the integrity of the data collected.

The sequence of study visits begins with an inclusion visit, also known as the screening visit, where potential participants are assessed for eligibility based on predefined criteria. This visit is crucial for ensuring that only suitable candidates are enrolled in the trial. Following successful inclusion, participants will undergo a series of follow-up visits at regular intervals. These visits are designed to monitor the participants' health status, assess the biodistribution of the PET scan, and collect data on any adverse events or side effects. The end-of-study visit marks the conclusion of the participant's involvement in the trial, where final assessments are conducted, and data is collected for analysis.

The expected length of participant involvement in the trial is approximately two years, aligning with the overall trial duration. However, certain conditions may lead to early termination from the study, such as the occurrence of severe adverse events, withdrawal of consent by the participant, or any other medical or ethical reasons deemed necessary by the study investigators. The trial is conducted in accordance with ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants throughout the study period.

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 these details limits the ability to describe the treatment regimen comprehensively.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on September 1, 2024, with an estimated completion date of September 1, 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 provided data. The trial will follow a structured timeline to ensure systematic data collection and analysis. The study will adhere to rigorous standards typical of Phase 3 trials, focusing on evaluating the treatment's effectiveness in a larger patient population. The trial's design will likely incorporate validated scales, laboratory tests, or patient-reported outcomes to measure efficacy, consistent with standard practices in clinical research. The absence of specific endpoints in the data suggests that these will be defined in the detailed trial protocol, ensuring comprehensive evaluation of the treatment's impact on the targeted medical condition.