Assessment of 64Cu-ATSM PET/CT as a Predictor of Neoadjuvant Therapy Response in Locally Advanced Rectal Adenocarcinoma

The primary objective of this study is to evaluate the efficacy of **64Cu-ATSM PET/CT** as a predictive tool for assessing the response to neoadjuvant therapy in patients with locally advanced **rectal adenocarcinoma**. This is clinically relevant as it may enhance the ability to tailor treatment plans based on individual tumor characteristics, potentially improving patient outcomes and optimizing therapeutic strategies.

The clinical trial involves participants diagnosed with **rectal adenocarcinoma**. The study population includes both male and female subjects, with an age range spanning from adults to the elderly. 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. The trial population was selected without emphasis on any particular vulnerable group, ensuring a broad representation of the general adult population.

The clinical trial is designed to evaluate the efficacy of **64Cu-ATSM PET/CT** as a predictor of response to neoadjuvant therapy in patients with locally advanced **rectal adenocarcinoma**. This study is a Phase 4 trial, which is categorized as a randomized, double-blind, controlled trial. The estimated recruitment start date was April 30, 2019, with an anticipated end date of July 1, 2025. The trial involves a series of structured study visits, beginning with an inclusion visit, where participants are screened for eligibility based on predefined criteria. This is followed by multiple follow-up visits to monitor the participants' response to the therapy and to collect necessary data. The trial concludes with an end-of-study visit, where final assessments are conducted to evaluate the primary and secondary endpoints.

Participants are expected to be involved in the study for its entire duration unless specific conditions necessitate early termination. Such conditions may include adverse reactions to the investigational product, withdrawal of consent, or any other medical or ethical reasons deemed significant by the study investigators. The trial's methodology ensures that data collected is robust and reliable, contributing valuable insights into the treatment of rectal adenocarcinoma. The study's design and procedures are meticulously planned to uphold the highest standards of clinical research, ensuring the safety and well-being of all participants throughout the trial period.

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. Consequently, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not included. The absence of this data precludes a comprehensive description of the treatments used in the study.

The clinical trial is in Phase 4, focusing on post-marketing surveillance to assess the efficacy of the intervention. The trial is scheduled to conclude by July 1, 2025, with recruitment having commenced on April 30, 2019. The efficacy of the treatment will be evaluated through a series of pre-determined endpoints, although specific primary and secondary endpoints are not detailed in the provided data. The trial will employ standard methodologies appropriate for Phase 4 studies, which typically involve the collection and analysis of data related to the treatment's effectiveness in a real-world setting. The assessment of efficacy will be conducted using validated tools and instruments, ensuring the reliability and accuracy of the results. The trial's design will adhere to rigorous scientific standards to provide meaningful insights into the treatment's performance post-approval.