Micro-CT and IVIS Imaging for Longitudinal Monitoring of Orthotopic Oncology Cell Therapy Efficacy

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Micro-CT and IVIS Imaging for Longitudinal Monitoring of Orthotopic Oncology Cell Therapy Efficacy

CELL & GENE | RNA | BIOLOGICS

    What is the primary advantage of combining Micro-CT and IVIS?

    A: Combining these modalities provides both high-resolution anatomical context (Micro-CT) and sensitive functional data on cell viability and proliferation (IVIS bioluminescence). This dual-data stream allows for a more complete assessment of therapeutic efficacy, distinguishing between tumor size reduction and changes in metabolic activity.

    How does longitudinal imaging support an IND submission?

    A: Longitudinal monitoring in the same animal cohort reduces biological variability and strengthens statistical power, providing a clear, continuous narrative of therapeutic response over time. This robust dataset is a key component for demonstrating efficacy and mechanism of action to regulatory bodies.

    Are these imaging studies compliant with GxP standards?

    A: All in vivo imaging studies at Franklin Biolabs are conducted within a GxP-compliant framework, ensuring data integrity, traceability, and adherence to the rigorous standards required for regulatory submissions. Our >100,000 sq ft facility is designed to support these programs.

    Can you accommodate custom orthotopic models?

    A: Yes. We specialize in developing and validating bespoke orthotopic models that accurately recapitulate the tumor microenvironment for specific cancer types, including complex cell therapy applications.

Longitudinal in vivo imaging is a requirement for accurately assessing the efficacy of oncology cell therapies in clinically relevant orthotopic models. The combination of Micro-CT for anatomical structure and IVIS for bioluminescent functional tracking provides a comprehensive, non-invasive method for monitoring tumor burden and therapeutic response over time. This dual-modality approach reduces cohort sizes and generates a robust, continuous dataset that supports a compelling IND package, typically within an 18-24 month timeline.

The Challenge in Monitoring Orthotopic Tumor Models

Evaluating cell therapies in orthotopic tumor models presents a significant challenge: accurately measuring therapeutic response in deep-tissue environments without relying on terminal endpoints. Traditional caliper measurements are unsuitable for internal tumors, and single-timepoint analyses can miss dynamic changes in tumor growth or regression.

Effective preclinical programs require methods that can:

  • Non-invasively track tumor growth and regression over time.

  • Differentiate between changes in tumor volume and cell viability.

  • Provide high-resolution anatomical context for precise localization.

  • Minimize inter-animal variability by using each subject as its own control.

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A Dual-Modality Approach: Micro-CT and IVIS

We utilize a synergistic imaging strategy to overcome these challenges. By integrating Micro-CT and IVIS imaging, we generate a multi-layered dataset that provides a complete picture of therapeutic activity. This approach delivers high-fidelity in vivo intelligence for complex modalities.

Imaging Modality Primary Data Output Key Advantage Application in Cell Therapy
Micro-CT High-resolution 3D anatomical scans Provides precise tumor volume, localization, and assessment of surrounding tissue architecture. Quantifies changes in tumor size and monitors structural impact on adjacent organs.
IVIS (Bioluminescence) 2D/3D light emission from luciferase-tagged cells Highly sensitive detection of viable tumor cells and their metabolic activity. Tracks real-time cell proliferation, apoptosis, and biodistribution of the therapeutic agent.

Driving Efficiency in Complex In Vivo Studies

Executing multi-modal, longitudinal imaging studies requires significant investment in technology and operational expertise. Our focus on process optimization allows us to deliver these complex datasets with greater efficiency, reducing development timelines and associated costs without compromising data quality.

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Building a Data-Rich Narrative for Regulatory Submission

A successful IND application depends on a clear and convincing preclinical data package. The strategic value of robust preclinical assessment is highlighted in advanced therapy development programs, which require demonstration of significant therapeutic benefits and a favorable safety profile (PMID: 35333110). While the specific therapeutic agent may differ, the principle remains constant: regulatory bodies require unambiguous evidence of efficacy and safety. Our longitudinal imaging strategies are designed to build this evidence base, contributing to a 100% IND success rate for programs initiated since 2019. (Franklin Biolabs brand launched in 2024).

Commitment to Animal Welfare

All in vivo studies are conducted with a strict adherence to the highest ethical standards for animal welfare. Our programs are AAALAC-accredited and USDA-registered. We are committed to the principles of the 3Rs (Replacement, Reduction, and Refinement), and non-invasive imaging techniques like Micro-CT and IVIS are central to our strategy for reducing the number of animals required for statistically significant results.

Scientific Process Diagram

This content is for informational purposes. For guidance specific to your therapeutic program, please contact our team for a consultation.

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