RAD 101 PET-mpMRI Detects All Brain Metastases in 22-Patient Study, Phase 2b Underway

A New Frontier in Brain Metastases Detection

Radiopharm Theranostics (ASX: RAD, NASDAQ: RADX) has unveiled compelling clinical data validating its novel radiotracer, RAD 101 (18F-Pivalate), as a highly effective tool for detecting brain metastases. Published in the European Journal of Nuclear Medicine and Molecular Imaging, the study showcases a hybrid imaging technique combining Positron Emission Tomography with Multiparametric Magnetic Resonance Imaging (PET-mpMRI) that successfully identified brain metastases in 22 patients, irrespective of prior radiation treatment or the primary tumor type.

This breakthrough is significant given the clinical challenge brain metastases present. Occurring up to four times more frequently than primary brain tumors, these secondary tumors often evade early and accurate detection, complicating treatment decisions and prognosis. RAD 101’s ability to highlight these lesions with a high tumor-to-background ratio marks a potential paradigm shift in neuro-oncology imaging.

Targeting Fatty Acid Metabolism in Cancer Imaging

Unlike traditional imaging agents that focus on glucose metabolism, RAD 101 exploits the upregulated fatty acid metabolism pathway common in many solid tumors, including cerebral metastases. By targeting fatty acid synthase transport and metabolism, RAD 101 provides a more precise visualization of cancer cells within the brain’s complex environment. This metabolic targeting was initially demonstrated in a smaller Phase 2a trial at Imperial College London, and the current larger study confirms these findings across a broader patient cohort.

Dr Eric Aboagye, lead inventor of RAD 101 and a professor at Imperial College London, emphasized the clinical implications: "Our work affirms how diverse cancers utilize fatty acids in the brain, enabling us to improve detection and open new avenues for therapeutic exploration." This insight not only enhances diagnostic capabilities but may also inform future treatment strategies targeting metabolic vulnerabilities.

Advancing Clinical Development with Phase 2b Trial

Building on these promising results, Radiopharm Theranostics has initiated a Phase 2b clinical trial in the United States, currently recruiting patients with suspected recurrent brain metastases from various solid tumors. This open-label, single-dose, multicenter study aims to rigorously evaluate RAD 101’s diagnostic performance in a real-world clinical setting, potentially setting a new standard for imaging in neuro-oncology.

CEO Riccardo Canevari highlighted the unmet need: "Current contrast-enhanced MRI, while standard, often struggles to differentiate between tumor progression and treatment effects such as radiation-induced changes. RAD 101 PET-mpMRI offers a more sensitive and specific alternative, which could transform patient management and outcomes."

Market and Clinical Implications

As systemic cancer therapies improve and patient survival extends, the incidence of brain metastases is rising, intensifying demand for advanced diagnostic tools. Radiopharm’s innovative approach positions RAD 101 as a potentially best-in-class imaging agent, with a pipeline that spans multiple solid tumor indications. The company’s dual listing on the ASX and Nasdaq underscores its ambition to capture a significant share of the oncology diagnostics market.

While the initial data is encouraging, the broader adoption of RAD 101 will depend on the outcomes of ongoing trials and regulatory approvals. Investors and clinicians alike will be watching closely as Radiopharm advances its clinical program and seeks to validate the clinical and economic benefits of this novel imaging technology.