Success Story: Accelerating Clinical Trials for Oncology with Imagenomix Predict and PathPresenter ConsultConnect
Zero-footprint web portals and AI-enhanced workflows reduce screening bottlenecks for an AKT-Pathway clinical trial
In Brief
- Oncology research trials require patients but enrollment can be a major limiter. 40% of oncology trials fail due to under-enrollment and 80% do not meet enrollment timelines
- Imagenomix addresses the enrollment challenge: Imagenomix’s Predict AI model for rapid mutation prediction from H&E slides speeds patient enrollment in clinical trials and lowers trial costs
- To recruit enough patients, clinical trials often include dozens of trial sites. This creates new challenges in collecting and aggregating data for analysis and reporting when those sites do not share the same laboratory and IT systems
- PathPresenter ConsultConnect solves the interoperability challenge by accepting and aggregating data from all trial sites into one data store, allowing efficient, concentrated and centralized analysis and reporting. Being cloud based, vendor-agnostic and built for interoperability, ConsultConnect requires no shared IT infrastructure or local software installation, and it accepts images from virtually any whole slide scanner or format.
The Challenge of Patient Enrollment
Clinical trials are the lifeblood of oncology research, providing the evidence that transforms promising therapies into approved treatments. Yet, patient enrollment remains one of the most persistent obstacles to trial success. Studies show that 40% of oncology trials fail due to under-enrollment, and 80% fail to meet enrollment timelines. The consequences are significant: delays in bringing lifesaving therapies to patients, higher trial costs, and incomplete or inconclusive data.
A key reason for insufficient enrollment lies in the complexity of matching the right patients to the right trial in timely fashion. Molecularly driven oncology trials depend on identifying specific genetic mutations, gene fusions, or molecular signatures in a patient’s tumor. These molecular biomarkers determine eligibility and help researchers understand which patients are most likely to benefit from an investigational therapy. Unfortunately, traditional laboratory workflows are slow, labor-intensive and expensive. Next-generation sequencing (NGS), while accurate, typically takes three to four weeks to deliver results and requires substantial tissue samples. The cost and delay not only slow patient enrollment but may also disqualify patients whose clinical status changes before testing is complete.
Accelerating Enrollment with AI
Imagenomix set out to solve this enrollment challenge by developing a faster, more scalable approach to patient screening through digital pathology and AI predictive models. Its IGX Predict AI-based technology analyzes the H&E-stained biopsy whole slide images that are already part of digital pathology workflows to predict the presence of key genetic mutations. Using advanced deep-learning models, IGX Predict identifies subtle histologic patterns correlated with genomic alterations, returning results in minutes instead of weeks. Predicted mutations are then confirmed by a multi-gene panel or a low-cost single gene assay, enabling clinical trial screening and enrollment even in low-income settings, for patients who do not have access to large NGS panels.
IGX Predict AI mutational screening enables clinicians and researchers to assess far more patients, more quickly, and at lower cost. Instead of waiting weeks for sequencing results, trial coordinators can rapidly identify patients who are likely to qualify for a given study and prioritize them for confirmatory testing or immediate enrollment. The result is faster trial startup, reduced screening costs, and greater access for patients who may benefit from investigational therapies.
By using AI to triage patients and predict mutation profiles, Imagenomix helps sponsors overcome one of the most critical barriers in oncology research: finding enough qualified participants to power statistically meaningful trials in a timely fashion.
From Enrollment Success to Data Management Complexity
In a current multi-site oncology study, the Imagenomix approach is enabling rapid enrollment across 45 clinical trial centers. With the enrollment hurdle cleared, a new challenge emerges: how to manage and harmonize the flood of data generated by dozens of institutions operating with different laboratory and IT infrastructures.
Each center has its own scanners, laboratory information systems (LIS), and compliance requirements. Some hospitals prohibit local software installation, making it difficult to deploy analysis tools or data transfer agents. Trial sponsors and investigators need a single, secure system to collect, store, and analyze digital pathology data from every site, regardless of scanner type, file format, or local IT policy.
Consistent, centralized access is also essential for quality control and reporting. Pharmaceutical sponsors require unified access to trial results and the ability to review data from all sites without the delays caused by manual data consolidation.
The Solution: PathPresenter ConsultConnect
To address these challenges, Imagenomix partnered with PathPresenter, integrating its ConsultConnect platform as the data backbone of the trial. Designed for multi-site, multi-platform interoperability, ConsultConnect is a cloud-based, vendor-agnostic solution that accepts images from virtually any whole-slide scanner or file format. It requires no local installation or shared IT infrastructure, making it ideal for diverse hospital environments with strict security policies.
Within days, PathPresenter deployed a secure ConsultConnect web portal on AWS specifically for the Imagenomix Predict platform. Using this platform, each pathology laboratory and trial site can safely upload data directly to the portal without any software installation, slide image adjustments or configuration burden. Each site sees only their respective cases while participating in a large multicenter study. The platform’s intuitive web interface built for pathologist by pathologists requires minimal training and facilitates rapid adoption across geographically distributed teams. Each site and each submitting pathologist has unique login credentials, providing traceability and ensuring no data leakage between sites.
Once uploaded, the data is automatically organized into a centralized repository. Imagenomix’s IGX Predict AI algorithms operate in the cloud to analyze the slides and generate mutation predictions. Results are seamlessly delivered back through the ConsultConnect portal, where they can be accessed by trial investigators and sponsors.
ConsultConnect’s robust healthcare-grade security and privacy controls ensure compliance with patient data protection regulations, while its scalable cloud architecture supports efficient, high-volume processing of digital slides.
Results and Impact
The combination of Imagenomix Predict and PathPresenter ConsultConnect is transforming the operational efficiency of the trial.
- Faster Trial Execution: With IGX Predict’s AI-based mutation prediction, patient identification that once took weeks now takes minutes, accelerating recruitment and trial initiation.
- Simplified Data Management: ConsultConnect eliminates the need for complex software deployments and manual data aggregation. All centers are able to contribute data seamlessly to a unified cloud environment.
- Enhanced Collaboration: Investigators and sponsors gain centralized visibility into results, supporting real-time collaboration and decision-making across sites.
- Improved Cost and Efficiency: Reduced reliance on costly molecular testing and streamlined data workflows translates into substantial savings in time, tissue and cost.
- Scalable Model for Future Trials: The success of this implementation establishes a repeatable, scalable model for future oncology and biomarker-driven studies involving multi-site data collection.
A Blueprint for the Future of Oncology Research
This case study illustrates how combining AI-driven mutation prediction with cloud-based interoperability can redefine the pace and efficiency of clinical research. Imagenomix Predict tackles the most pressing barrier of patient enrollment, while PathPresenter ConsultConnect resolves the data-logistics challenge inherent in large, distributed trials.
Together, they enable sponsors to run faster, more cost-effective studies without compromising scientific rigor or patient privacy. As oncology trials continue to grow in complexity and precision, such integrated, interoperable technologies will be indispensable in bringing the next generation of targeted therapies to patients worldwide.
More Information
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