Dosimetry Study of uPAR-Targeted Radioligand Therapy in Glioblastoma Patients

The primary objective of this study is to evaluate the **dosimetry** of uPAR targeted radioligand therapy in patients diagnosed with **glioblastoma**. This is clinically relevant as it aims to determine the distribution and radiation dose delivered to the tumor and surrounding tissues, which is crucial for optimizing therapeutic efficacy and minimizing adverse effects. The study does not specify any secondary objectives.

The clinical trial involves participants diagnosed with **glioblastoma**, a highly aggressive form of brain cancer. The study population includes both male and female subjects, with an age range encompassing 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. Selection criteria and lifestyle considerations such as diet, physical activity, or habits have not been detailed by the sponsor. The trial aims to include a diverse group of participants to ensure comprehensive data collection and analysis.

The clinical trial is designed to evaluate the efficacy and safety of a novel treatment for **glioblastoma**. This study is a Phase 3, randomized, double-blind, controlled trial, which aims to provide robust data on the therapeutic potential of the investigational product. The trial is expected to commence recruitment on October 15, 2025, and is projected to conclude by May 15, 2026. Participants will be randomly assigned to either the treatment group or the control group, ensuring that neither the participants nor the investigators are aware of the group assignments, thus maintaining the integrity of the study results.

The sequence of study visits begins with an inclusion visit, where potential participants undergo a screening process to determine eligibility based on predefined criteria. Following successful enrollment, participants will attend regular follow-up visits at specified intervals to monitor their health status, assess treatment efficacy, and record any adverse events. The end-of-study visit marks the conclusion of the participant's involvement, where final assessments are conducted to gather comprehensive data on the treatment's impact.

The expected length of participant involvement in the trial is approximately seven months, from the initial screening to the end-of-study visit. Conditions that may lead to early termination from the study include the occurrence of significant adverse events, withdrawal of consent by the participant, or any other medical or ethical reasons deemed necessary by the investigators. The trial's design and procedures are structured to ensure the collection of high-quality data while prioritizing participant safety and adherence to ethical standards.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the study may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatments. However, the data does not provide explicit details about these treatments, including their names, dosages, or administration routes. The trial documentation does not specify any additional relevant information about drug administration, dosing schedules, or participant compliance monitoring.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on October 15, 2025, with an estimated completion date of May 15, 2026. The efficacy assessment will be conducted through a series of predefined parameters, although specific endpoints are not detailed in the available data. The trial will follow a structured timeline to ensure systematic data collection and analysis. The methodology for measuring and analyzing efficacy parameters will adhere to standard clinical trial protocols, ensuring the reliability and validity of the results. The trial's design and execution will be aligned with regulatory requirements and scientific standards to evaluate the therapeutic benefits accurately.