Dosimetry Study of the Novel Amino Acid PET Tracer [18F]FELP in Patients with Glioblastoma

The primary objective of this study is to evaluate the **dosimetry** of a novel amino acid PET tracer, [18F]FELP, in patients with **glioblastoma**. This is clinically relevant as accurate dosimetry is crucial for optimizing the safety and efficacy of PET imaging, which is essential for the diagnosis and management of glioblastoma. Understanding the distribution and radiation dose of [18F]FELP can aid in improving imaging protocols and patient outcomes.

The clinical trial involves participants diagnosed with **glioblastoma**, a highly aggressive form of brain cancer. The study population includes both male and female subjects, encompassing a broad age range from adolescents to older adults. The trial specifically includes vulnerable populations, although the exact number of participants has not been disclosed by the sponsor. Participants were selected based on criteria that are not detailed in the provided data. Lifestyle factors such as diet, physical activity, and habits have not been specified. The trial aims to gather insights from a diverse group, reflecting a wide spectrum of the general health status associated with the condition.

The clinical trial is designed to evaluate the **dosimetry** of a novel amino acid PET tracer, [18F]FELP, in patients diagnosed with **glioblastoma**. This study is a Phase 1 trial, which will be conducted in a randomized, double-blind, and controlled manner to ensure the reliability and validity of the results. The trial is expected to commence on January 8, 2024, with an estimated completion date of March 8, 2027, providing a comprehensive evaluation period for the investigational tracer.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized into the study groups. The trial will include multiple follow-up visits to monitor the safety and efficacy of the tracer, as well as to collect necessary data for dosimetry analysis. The end-of-study visit will conclude the participant's involvement, during which final assessments will be conducted to gather comprehensive data on the tracer's performance.

The expected length of participant involvement will vary depending on individual response and adherence to the study protocol. However, participants are anticipated to be involved for the duration of the trial unless specific conditions necessitate early termination. Such conditions may include adverse reactions, withdrawal of consent, or any other protocol-defined criteria that compromise participant safety or data integrity. The trial is structured to ensure that all procedures are conducted in accordance with ethical standards and regulatory requirements, providing a robust framework for evaluating the investigational tracer's potential in treating glioblastoma.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the lack of specific data, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be detailed. The absence of this information precludes the provision of a comprehensive description of the treatments used in this clinical trial.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, with an estimated recruitment start date of January 8, 2024, and an estimated end date of March 8, 2027. The efficacy assessment will be conducted using predefined parameters or endpoints, although specific details regarding these endpoints are not provided in the available data. The trial will follow a systematic approach to measure, collect, and analyze efficacy data, adhering to the standards expected in clinical research. The methods and schedule for these assessments will be aligned with the trial's objectives and regulatory requirements, ensuring the reliability and validity of the findings. The trial will employ appropriate tools and instruments for efficacy assessments, although specific instruments are not mentioned in the provided information. The data collected will contribute to understanding the efficacy profile of the investigational product within the context of the trial's objectives.