Excellent Practices

Research

Practice Category: Research

Centre: Karolinska Institute and University Hospital

Thuy Tran

Head of TTC and Resercher at KI

thuy.tran@regionstockholm.se

Challenge addressed by the practice

Theranostics Trial Center (TTC) tackles the complexity of combining diagnostic imaging and the therapeutic use of radiolabelled drugs (theranostics) within a single, streamlined clinical framework—bridging two traditionally separate domains for precise, image guided treatment.

Solution

The center focuses on early-phase clinical trials to evaluate new radiopharmaceuticals. This involves:

  • Assessing safety, biodistribution, pharmacokinetics (how the radiopharmaceutical is distributed in the body) 
  • Performing dosimetry (how much radiation the body receives), target engagement, and imaging feasibility

Theranostics requires close collaboration across specialties, including nuclear medicine, medical physics, oncology, radiopharmacy, and clinical research. TTC brings these diverse teams together to facilitate translation from early drug development to the clinic.

By identifying and targeting only those tumours that express the chosen molecular target, theranostics helps avoid the risks and side effects of non-beneficial treatments, ultimately improving patients’ quality of life.

The center relies on cutting-edge facilities, including cyclotrons, radiochemistry labs, and imaging infrastructure, to support complex tracer development and enable rigorous clinical trials.

Impact

  • Theranostics helps address the challenge of selecting the right patients, based on biomarkers revealed through diagnostic imaging, ensuring therapies are targeted and effective.
  • Acts as the hub for Theranostics Trial Alliance (TTA) Sweden, a national network in Sweden.
  • Coordinates multicenter trials and partnerships with academia and industry.

TTC has catalysed foundational infrastructure, networks, and translational workflows. These efforts indicate a meaningful shift in Swedish/Scandinavian cancer research, emphasising precision theranostic trials, efficient patient stratification, and health-economic evaluation.

Critical success factors

Bringing together diverse expertise—nuclear medicine, medical physics, radiopharmacy, oncology, imaging, molecular biology, and clinical trial specialists—has enabled seamless integration of diagnostics and therapy under one umbrella. 

Building state-of-the-art facilities, including radiochemistry labs and nuclear medicine imaging systems, has been essential for developing and validating novel radiopharmaceuticals.

Investment in workforce development—training nuclear medicine staff, radiochemists, and clinical trial experts—ensures sustainability and addresses a global bottleneck in theranostics implementation.

Factors like expert collaboration, robust infrastructure, policy-aligned funding, standardised processes, networked trials, economic justification, leadership, training, as well as close collaboration with patient organisation, have collectively underpinned the rapid and successful establishment of theranostic capabilities at Karolinska and across Sweden.

Next steps

Expansion of Clinical Trials

  • Broader research on other targets, and inclusion of other tumour types with high unmet clinical need, beyond neuroendocrine and prostate cancers (e.g., breast, lung, and pancreatic), as well more effective radionuclide therapies such as alpha emitters and combination therapy
  • Collect and publish real-world evidence on survival, quality of life, and toxicity profiles
  • Benchmark against standard-of-care treatments and build health economics foundation for implementing these new treatments in clinical routines

Thuy Tran