Nuclear Medicine & Imaging Core Lab

For nearly a decade, the Axcellant team has built unique expertise in managing nuclear medicine clinical trials, from first-in-human dosimetry studies through Phase III registration trials, including intricate international projects.

Collaborating within cross-disciplinary teams—including oncologists, cardiologists, neurologists, endocrinologists, and nuclear medicine specialists—requires an in-depth understanding of the unique dynamics and specifics inherent in nuclear medicine trials.

Our dedicated team supports clients throughout the entire process, from Technology Transfer Management to logistics and operational execution.

Trials with Diagnostic Radiopharmaceuticals and Theranostics

Axcellant team has extensive expertise in managing clinical trials with diagnostic radiopharmaceuticals and theranostics, spanning from first-in-human studies to late-phase trials. We specialize in employing PET and SPECT imaging tracers like Fluorine-18 and Lutetium-177 to deliver insights into disease mechanisms and diagnostic efficacy.

Theranostics combines diagnostic imaging with targeted radiopharmaceutical therapy, offering a personalized approach to patient care. Our team is proficient in designing and executing theranostic trials that utilize radiopharmaceuticals and is capable of both imaging and therapeutic functions. For instance, Lutetium-177-labeled compounds are employed in targeted radionuclide therapy to deliver radiation directly to tumor cells while minimizing exposure to healthy tissues. Managing theranostic trials requires a nuanced understanding of both diagnostic and therapeutic modalities.

We specialize in managing clinical trials for diagnostic software classified as medical devices, offering tailored support to ensure regulatory compliance and smooth trial execution. Our expertise centers around integrating advanced software solutions that enhance diagnostic accuracy and streamline data analysis. We have experience with medical devices such as radioactive microspheres used in selective internal radiation therapy (SIRT).

What Imaging Core Lab Services Mean to Us

Drawing on our experience, we collaborate closely with Key Opinion Leaders and leading scientific institutions to strengthen the quality and innovation of nuclear medicine trials. 

Axcellant partners with world-class PET Core Lab experts from Turku University (EU), Saint Luke’s Hospital (USA), and Cedars-Sinai Medical Center (USA), seamlessly integrating services into nuclear medicine projects for precise, reliable results. We see imaging not only as a tool for capturing diagnostic images but also as a critical method for evaluating imaging biomarkers and endpoints. This comprehensive approach enables us to generate reliable data that drives informed decision-making and optimizes trial outcomes.

In nuclear medicine, specialized imaging software is essential for the accurate analysis and interpretation of diagnostic data. Notable examples include QPET from Cedars-Sinai, offering advanced quantification for cardiac PET studies, and INVIA’s 4DM, providing comprehensive tools for nuclear cardiology imaging. Additionally, Cardiovascular Imaging Technologies (CVIT) has developed Imagen3D, an advanced software application for processing, analyzing, and displaying cardiac PET and SPECT images, aiding in the detection of cardiac diseases. At Axcellant, we maintain an agnostic stance toward imaging software, ensuring our team is proficient across diverse platforms to meet the specific needs of each clinical trial.

How We Support Clinical Trials with Imaging

Our process is designed to seamlessly integrate study imaging (PET & MR) into your clinical trials, ensuring robust support at every stage:

1. Imaging Data Processing: Implementing standardized imaging procedures to ensure consistent and high-quality image collection across all trial sites. By collaborating with qualified personnel and utilizing validated imaging protocols, we achieve reliable and accurate data for clinical evaluation.
2. Imaging Protocol Design: Developing tailored imaging protocols that meet the specific needs of each trial.
3. Quality Control: Implementing rigorous quality checks to guarantee the accuracy and reliability of imaging data.
4. Trial Integration: Coordinating closely with clinical teams to ensure that imaging endpoints are effectively incorporated into the trial design.

Nuclear Medicine & Imaging Core Lab Services

Axcellant offers a comprehensive suite of imaging services, including:

• Clinical Trial Imaging Services: Delivering detailed and high-quality imaging data for clinical research.
• Data Analysis: Leveraging advanced imaging software and expert analytics to extract actionable insights from imaging results.
• Imaging Protocol Support: Developing, standardizing, and customizing imaging protocols to meet the specific scientific and operational needs of each trial, ensuring reproducibility and consistency.
• Imaging Site Management: Providing qualification, training, and support for imaging sites to maintain adherence to protocol requirements and quality standards.
• Centralized Image Review: Facilitating image review by qualified experts to ensure uniform assessment criteria and minimize inter-reader variability.

We have experience in supporting clients with the development of documentation tailored to the unique requirements of nuclear medicine trials. Our expertise extends to creating a comprehensive Imaging Charter, designing detailed procedures for radiopharmaceutical handling, imaging workflows, and quality assurance measures.

Rely on Axcellant for Centralized Expert Imaging Services

Trust Axcellant to deliver expert imaging solutions that elevate your clinical trial performance. With advanced imaging technology and a dedicated core lab team, we provide reliable, innovative imaging support every step of the way. Reach out today to discover how our Nuclear Medicine & Imaging Core Lab services can transform your clinical trials.