Multiparametric Dynamic Whole-Body 68Ga-PSMA PET Imaging for Recurrence Detection in Hepatocellular Carcinoma: HIMIKO Study

The primary objective of this study is the **evaluation** of multiparametric dynamic whole-body 68Ga-PSMA PET imaging for the detection of **recurrence** in patients with **Hepatocellular carcinoma**. This imaging modality is being assessed for its potential to improve the accuracy of detecting recurrent disease, which is crucial for timely and appropriate clinical management. Early and precise identification of recurrence can significantly impact treatment decisions and patient outcomes.

The clinical trial involves participants diagnosed with **hepatocellular carcinoma**. The study population includes both male and female subjects, with an age range encompassing adults and older adults. The trial population selection criteria and the total number of participants have not been disclosed by the sponsor. Participants may include individuals from vulnerable populations. Information regarding specific lifestyle considerations such as diet, physical activity, or habits has not been provided. The sponsor has not specified any key inclusion or exclusion criteria for this study.

The clinical trial is designed to evaluate the efficacy of **multiparametric dynamic whole-body 68Ga-PSMA PET imaging** in detecting recurrence of **hepatocellular carcinoma**. The study is structured as a randomized, double-blind, controlled trial, ensuring that neither the participants nor the researchers know which participants belong to the control group or the experimental group, thus minimizing bias. The trial is set to commence recruitment on June 1, 2025, and is expected to conclude by June 1, 2027, spanning a total duration of approximately two years.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, where eligibility criteria are assessed. This visit is crucial for determining participant suitability based on predefined inclusion and exclusion criteria. Following successful screening, participants will be enrolled in the study and randomized into respective groups. Throughout the trial, follow-up visits will be scheduled at regular intervals to monitor the participants' health status, adherence to the study protocol, and any adverse events. These visits are essential for collecting data on the primary and secondary endpoints of the study.

The end-of-study visit marks the final assessment of the participants, where comprehensive evaluations are conducted to gather conclusive data on the trial's outcomes. The expected length of participant involvement is contingent upon the study's timeline, with each participant anticipated to be involved for the duration of the trial unless early termination is warranted. Conditions that may lead to early termination include significant protocol deviations, adverse events that compromise participant safety, or voluntary withdrawal by the participant. The trial's design and procedures are meticulously crafted to ensure the integrity and reliability of the collected data, contributing to the advancement of knowledge in the management of hepatocellular carcinoma.

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 through a structured evaluation process. The trial is scheduled to commence recruitment on June 1, 2025, with an estimated completion date of June 1, 2027. The trial is categorized under phase 9, indicating an advanced stage of clinical research. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, the trial will likely employ standard methodologies for measuring and analyzing efficacy outcomes. These may include validated scales, laboratory tests, or patient-reported outcomes, assessed at predetermined timepoints throughout the trial duration. The absence of explicit endpoints suggests that the trial may focus on comprehensive data collection to evaluate the therapeutic impact of the intervention under investigation. The trial's design will adhere to rigorous scientific standards to ensure the reliability and validity of the efficacy assessments.