Neurology’s Radiotheragnostic Turn: SNMMI Signals an Imaging-Led Therapeutic Revolution

Intro

Radiopharmaceuticals are expanding their clinical reach and SNMMI 2025 made it clear that neurology is next. From Alzheimer’s disease to glioblastoma, nuclear imaging is no longer limited to diagnostics. It’s becoming a tool for trial enrichment, patient stratification, and even therapeutic guidance. Neurology’s theragnostic advances are reshaping how we design and deliver care.

Positron emission tomography (PET) is the primary modality driving this evolution. Its ability to visualize molecular processes in vivo—through target-specific radiotracers—is enabling a new class of trial endpoints across CNS diseases. These radiotracers, designed to bind to biomarkers like tau, amyloid, or SV2A, offer more than diagnostic clarity: they’re becoming tools for cohort selection, treatment planning, and biological response assessment. As neurology trials grow more targeted, PET is increasingly driving protocol design, not just supporting it.

Here’s what biotech teams, imaging developers, and investors should know about this pivotal turn.

1. Alzheimer’s Imaging Is Shifting Toward Trial Utility

For years, PET tracers like [¹⁸F]-Flortaucipir (Tauvid®) and [¹⁸F]‑florbetaben have supported Alzheimer’s diagnostics by confirming the presence of tau and amyloid plaques. But newer-generation agents are advancing clinical impact. SNMMI 2025 featured promising data on [¹⁸F]-MK-6240 and [¹⁸F]-PI-2620, both of which outperformed existing tracers in post-mortem validation studies [1]. A new tracer, [¹⁸F]‑SNFT-1, also showed higher sensitivity and lower off-target binding, which are key traits for early intervention [2].

These advancements support a broader strategic shift: using PET imaging not just to confirm disease, but to select trial participants, track response, and define progression with greater accuracy and timing.

Theragnostic Insight: Sponsors developing Alzheimer’s or tau-targeting programs should evaluate whether newer-generation tracers can strengthen their trial endpoints or enable exploratory biomarkers. Imaging decisions should be locked early to support IND discussions and phase transition plans.

2. PET Is Gaining Ground in Brain Tumor Management

In neuro-oncology, theragnostic thinking is evolving fast. Researchers at SNMMI 2025 shared updates on PET tracers targeting fibroblast activation protein (FAP), somatostatin receptors (SSTR), and prostate-specific membrane antigen (PSMA); agents now being applied to glioblastoma and meningioma imaging [3].

Most notably, new guidelines from Response Assessment in Neurooncology (RANO), Society of Nuclear Medicine and Molecular Imaging (SNMMI), European Association of Neurooncology (EANO), and European Association of Nuclear Medicine (EANM) established standardized procedures for SSTR PET in meningioma, paving the way for reimbursement and multi-site protocol adoption [4][7]. Several early-phase trials are now integrating these tracers not only for diagnosis but for eligibility screening, surgical planning, and even radiotherapy personalization.

Theragnostic Insight: Brain tumor teams should consider how FAP-, SSTR-, or PSMA-targeted imaging may support enrollment criteria, dose optimization, and treatment planning, especially when pathology or location limits biopsy. PET can also provide longitudinal insight where MRI alone may be insufficient.

3. Neuroinflammation and Synaptic Density Are Strategic Targets

SNMMI also highlighted growing interest in PET imaging for neuroinflammation and synaptic density, especially in conditions like multiple sclerosis and Parkinson’s disease. Tracers targeting the translocator protein (TSPO) and synaptic vesicle glycoprotein 2A (SV2A) offer a dynamic readout of neuronal integrity and immune activation, which were biological signals previously inaccessible in real time.

Several programs are now incorporating these tools as exploratory endpoints to refine inclusion criteria, support dose-response modeling, or monitor target engagement. In diseases where symptoms are variable and progression is slow, these biomarkers may help drive earlier and more confident decision-making.

Theragnostic Insight: When traditional clinical scales fall short, imaging can reveal meaningful biological change. Teams should explore how PET can offer trial-ready insights for diseases where function-based endpoints lag behind mechanism.

4. PET Is a Priority for Investors When Used Strategically

SNMMI 2025 investor sessions reinforced a clear trend: neuroimaging is scientifically exciting and commercially relevant. CMS reimbursement for Alzheimer’s PET, growing pharma investment in CNS pipelines, and increased trial volume, including novel tracer development in early-phase studies [8], all point to long-term viability. But investors are asking more detailed questions:

• Is the imaging platform linked to a specific therapeutic use case?

• Is there operational readiness for imaging at scale?

• Are timelines and costs aligned with the therapeutic development plan?

Programs with pre-defined imaging strategy, regulatory alignment, and proven workflow integration tend to stand out. The strongest investment cases show imaging not only as a differentiator, but as a driver of time and cost efficiency across the clinical pathway.

Theragnostic Insight: To attract investment, teams must show that imaging isn’t an afterthought. Articulate how PET supports trial decisions, informs market access, and strengthens differentiation early, especially in CNS, where outcome variability often delays traditional readouts.

What This Means for Biotech and Pharma

The neurotheragnostic field is shifting from early promise toward meaningful execution. Radiopharmaceutical tools are increasingly used not only for diagnosis but also to define patient populations, validate mechanisms, and guide therapeutic decisions. Imaging-driven strategies in other areas, including prostate cancer [5][6], reinforce this shift toward integrated clinical utility. Alzheimer’s, glioblastoma, Parkinson’s, and depression are no longer viewed in isolation, they represent active areas of integrated theragnostic development.

At Theragnostic Insights, we support biotech, pharma, and health systems in translating neuroimaging innovation into trial-ready strategy. From early tracer selection to protocol development and regulatory navigation, we bring operational clarity and clinical insight to advance your program with confidence.

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That’s a wrap on our SNMMI 2025 mini-series.
From clinical innovation to regulatory readiness to theragnostic expansion in neurology, we’ve unpacked how radiopharmaceuticals are moving from concept to clinic—and what that means for teams building the future of precision care.

Read the full SNMMI mini-series here:

1. From the SNMMI Frontlines: 5 Takeaways Reshaping Radiopharmaceutical Strategy

2. Theragnostics in the Wild: How Real-World Oncology Trials Are Rewriting the Radiopharmaceutical Playbook

3. From Insight to Implementation: What Investors and Health Systems Need to Know About Radiopharmaceutical Maturity‍

4. Neurology’s Radiotheragnostic Turn: SNMMI Signals an Imaging-Led Therapeutic Revolution

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References:

[1] Aguero C, Dhaynaut M, Amaral AC, Moon SH, Neelamegam R, Scapellato M, Carazo-Casas C, Kumar S, El Fakhri G, Johnson K, Frosch MP, Normandin MD, Gómez-Isla T. Head-to-head comparison of [18F]-Flortaucipir, [18F]-MK-6240 and [18F]-PI-2620 postmortem binding across the spectrum of neurodegenerative diseases. pubmed.com

[2] SNMMI, 2025. Novel Tau PET Tracer ¹⁸F-SNFT-1 Shows High Sensitivity and Specificity. snmmi.org

[3] Frontiers in Nuclear Medicine, 2023. PET tracers in glioblastoma: Toward neurotheranostics as an individualized medicine approach. frontiersin.org

[4] Journal of Nuclear Medicine, 2024. Joint SSTR PET Imaging Guidelines for Meningioma from RANO, SNMMI, EANO, and EANM. jnm.snmjournals.org

[5] UroToday, 2025. SNMMI 2025: ¹⁸F Piflufolastat PET/CT in Patients with Biochemically Recurrent Prostate Cancer: A CONDOR Sub Analysis. Positive predictive value stratified by PSA level in recurrent prostate cancer:: A CONDOR Sub-Analysis of Positive Predictive Value in the Prostate/Prostatic Bed Stratified by PSA. Urotoday.com

[6] UroToday, 2025. SNMMI 2025: Evaluation of PSMA PET/CT Derived Predictors for Treatment Response to ¹⁷⁷Lu PSMA 617. Predictive value of baseline imaging in expanded access program for prostate cancer. Urotoday.com

[7] SNMMI, 2023. Joint EANM/SNMMI Procedure Guideline for PSMA PET/CT Imaging. Standardized acquisition and interpretation framework for PSMA-targeted PET imaging. snmmi.org

[8] UroToday, 2025. SNMMI 2025: A Phase I Trial of ⁶¹Cu NODAGA PSMA I&T for Patients with Prostate Cancer. Early-phase development of novel PET tracer in prostate cancer. Urotoday.com

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