Mayo Clinic and GE HealthCare have launched a groundbreaking study that uses AI-powered imaging and biomarker data to personalize cancer treatment decisions, moving away from one-size-fits-all therapy protocols. The MI-BET (Molecular Imaging Biomarker-Based End of Therapy Trial) research collaboration will evaluate whether imaging insights and blood-based biomarkers can help doctors adapt radioligand therapy (RLT) for patients with advanced prostate cancer, potentially allowing treatment pauses based on individual patient response rather than preset therapy cycles.

What Is Theranostics and Why Does It Matter?

Theranostics combines targeted diagnostic imaging with therapeutic treatment in a single approach. Radioligand therapy, the focus of this study, uses radiopharmaceuticals that can both identify cancer cells and deliver targeted radiation to destroy them. Today, most patients receiving RLT follow a standardized number of treatment cycles regardless of how well their cancer responds. The MI-BET study challenges this approach by exploring whether real-time imaging data can inform more adaptive, personalized decisions.

The collaboration stems from a 2023 Strategic Radiology Research Alliance between Mayo Clinic and GE HealthCare, designed to transform how radiology and novel therapies are delivered. By integrating imaging data with clinical outcomes and blood-based biomarkers, researchers hope to develop predictive markers that could help clinicians anticipate how patients will respond before or early in treatment.

How Will the Study Use AI and Imaging Technology?

The MI-BET research will leverage two key technologies to track tumor response throughout therapy:

• GE HealthCare's StarGuide SPECT/CT Technology: Advanced imaging equipment that provides detailed scans to monitor how tumors respond to radioligand therapy over time.
• MIM Software's MIM LesionID Pro: AI-powered software that analyzes imaging data to track individual lesions and assess treatment response patterns.
• Blood-Based Biomarkers: Laboratory measurements that provide additional clinical data to inform treatment decisions alongside imaging insights.

By combining these data sources, the research team aims to generate insights that could support more individualized treatment decisions and potentially reduce unnecessary therapy while expanding access to care for wider patient populations.

"Personalizing therapy is both a scientific pursuit and an opportunity to expand patient access. Theranostics, and studies such as MI-BET, give us an important opportunity to rethink how and when we treat cancer. By evaluating response earlier in their treatment, we can generate data to drive approaches that could help reduce unnecessary therapy while expanding access to care for wider populations," said Geoffrey Johnson, M.D., Ph.D., chair of the Radiopharmaceutical Trial Team at Mayo Clinic Comprehensive Cancer Center.

Geoffrey Johnson, M.D., Ph.D., Chair of the Radiopharmaceutical Trial Team at Mayo Clinic Comprehensive Cancer Center

How Does This Approach Expand Patient Access?

One of the study's key goals is to make advanced theranostic care available to a broader range of patients. The research is designed to encourage broad participation through patient outreach, collaboration with community and advocacy organizations, and the use of telemedicine approaches that may reduce barriers to enrollment and engagement. This focus on accessibility reflects a growing recognition that precision medicine innovations must reach diverse patient populations to have meaningful impact.

Mayo Clinic will conduct the MI-BET research at its Rochester, Minnesota campus, leveraging both organizations' strengths in clinical practice, research, and product development. Additionally, Mayo Clinic is the first U.S. site to investigate GE HealthCare's next-generation SPECT/CT StarGuide GX technology, which is designed to reduce scan time and increase precision in tumor assessments.

"Making theranostics truly adaptive and personalized requires strong clinical evidence and a deeper understanding of how patients respond to therapy. Through our collaboration with Mayo Clinic, we are exploring how imaging and data-driven insights can help inform more individualized treatment decisions, support the broader adoption of these approaches and contribute to the continued growth of precision care in oncology," noted Sergio Calvo, global general manager of Theranostics at GE HealthCare.

Sergio Calvo, Global General Manager, Theranostics at GE HealthCare

What Does This Mean for the Future of Cancer Treatment?

The MI-BET study represents a broader shift in oncology toward adaptive, patient-specific care models. Rather than treating all patients identically, clinicians increasingly recognize that cancer response varies significantly between individuals. By using AI-powered imaging and biomarker data to track these differences in real time, doctors can make treatment decisions that are tailored to each patient's unique disease trajectory.

This approach has potential implications beyond prostate cancer. The research methodology and insights generated could inform how other cancers are treated with radioligand therapy and other precision medicine approaches. As healthcare systems continue to adopt AI-powered diagnostic tools, studies like MI-BET provide crucial evidence about how these technologies can improve patient outcomes while reducing unnecessary treatment burden.

"This collaboration is an example of how Mayo Clinic leads in discovery by integrating novel technologies into our practice and accelerating innovation across research and clinical care to advance the future of medicine. By bringing together complementary expertise and capabilities, we can enable our world-class researchers and physicians to develop new insights, expand treatment possibilities, and ultimately provide the best outcomes for our patients globally," explained Andrew Danielsen, chief business development officer at Mayo Clinic.

Andrew Danielsen, Chief Business Development Officer at Mayo Clinic