For most patients receiving radioligand therapy (RLT) for advanced prostate cancer, treatment follows a fixed number of cycles regardless of how their body is responding. A new research collaboration between GE HealthCare and Mayo Clinic wants to change that.
The two organizations have announced the MI-BET trial, short for Molecular Imaging Biomarker-Based End of Therapy Trial. The study is designed to test whether combining imaging data with blood-based biomarkers can give doctors enough information to adapt treatment in real time, potentially pausing therapy when a patient’s disease response warrants it rather than completing a preset course.
The project grows out of a broader Strategic Radiology Research Alliance the two organizations signed in 2023. That agreement was built around advancing both diagnostic and therapeutic radiology, and MI-BET is one of its first concrete outputs. Theranostics, the field this study sits within, pairs targeted diagnostics with targeted therapy so clinicians can identify and treat cancer using the same biological pathway.
How the study works
MI-BET will be based at Mayo Clinic’s campus in Rochester, Minnesota. The research team will use GE HealthCare’s StarGuide SPECT/CT scanner alongside MIM Software’s MIM LesionID Pro to monitor how tumors respond throughout a course of RLT.
By combining that imaging data with clinical outcomes and biomarkers from blood tests, the team hopes to build a clearer picture of each patient’s individual response. The key question is whether those combined signals can support decisions about when to pause or modify treatment, rather than waiting for a predetermined endpoint.
The study also aims to identify predictive markers, biological signals that could tell doctors how a patient is likely to respond before or early in treatment. That kind of early insight would give clinicians more room to make adaptive decisions.
Why this matters for patients
Geoffrey Johnson, chair of the Radiopharmaceutical Trial Team at Mayo Clinic Comprehensive Cancer Center, put the clinical stakes plainly: “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.”
That access piece is built into the study’s design. Mayo Clinic says MI-BET will actively work to encourage broad participation through:
- Patient outreach and community partnerships
- Collaboration with advocacy organizations
- Telemedicine options to reduce barriers to enrollment
The goal is to make sure the benefits of more personalized theranostics reach patients beyond major academic medical centers.
The technology behind it
The StarGuide SPECT/CT system from GE HealthCare is a digital imaging platform designed for precision nuclear medicine imaging. Mayo Clinic is also the first U.S. site to explore GE HealthCare’s next-generation StarGuide GX, which is being evaluated for its potential to reduce scan time and improve the precision of tumor assessments. The StarGuide GX has CE marking in Europe but has not been approved or cleared by the FDA and is not available for sale in the United States.
MIM LesionID Pro adds automated lesion tracking on top of the imaging hardware, giving researchers a consistent way to measure tumor response across a patient’s treatment course.
The bigger picture in oncology
Theranostics has gained significant momentum in recent years, particularly in prostate cancer. Lutetium-177 PSMA therapy, approved by the FDA in 2022, showed that targeting a specific protein on cancer cells with a radioactive molecule could extend survival in patients with advanced disease. The field has since attracted heavy investment from pharmaceutical and medtech companies alike.
What MI-BET is trying to do, though, goes a step further. Rather than simply proving a therapy works, it is asking how to use it smarter, getting the same or better outcomes while avoiding treatment that isn’t needed. Sergio Calvo, GE HealthCare’s global general manager for Theranostics, framed it this way: “Making theranostics truly adaptive and personalized requires strong clinical evidence and a deeper understanding of how patients respond to therapy.”
If the study produces usable predictive markers, it could influence how RLT is delivered well beyond Mayo Clinic, giving oncologists across the field a more principled way to decide when a patient has had enough treatment and when they need more.