Nuclidium Launched Phase 2 Cancer Imaging Trial
The clinical study is testing a new PET imaging agent in patients with metastatic prostate cancer.
Updated on Oct. 6, 2026 in Cancer
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Nuclidium has imaged the first patient in a Phase 2 trial of its diagnostic radiotracer, 61Cu-NU101. The study is enrolling 34 patients across the United States to evaluate the agent's performance in detecting metastatic prostate cancer lesions.
Why it matters
The trial builds on Phase 1 data that showed the agent to be safe and effective, potentially offering a more precise method for identifying tumors. The imaging agent is part of a broader theranostic program designed to improve diagnostic accuracy for prostate cancer patients.
In Phase 1, the 61Cu-NU101 agent detected additional lesions in 50% of patients compared to sensitive agents. The diagnostic agent is notable for its rapid manufacturing time, requiring only 5 minutes at room temperature.
The players
NUCLIDIUM
This biotechnology company is developing a theranostic pipeline for cancer treatment and diagnosis with headquarters in Basel, Switzerland, and Munich, Germany.
The details
Participants receive a single intravenous dose of the radiotracer, which binds to the Prostate-Specific Membrane Antigen, followed by PET/CT imaging at 1 and 4 hours. The Phase 2 study aims to measure the sensitivity of this agent against standard FDA-approved 18F-based options.
Timeline
Phase 1 data was presented in 2025 at the SNMMI Annual Meeting.
The first patient was imaged in the Phase 2 trial on October 6, 2026.
The Big Picture
This development follows the trajectory of the development of Prostate-Specific Membrane Antigen PET imaging agents. It advances the field by moving from initial safety testing to large-scale sensitivity analysis.
This trial represents a potential shift in how metastatic prostate cancer is mapped, which may eventually lead to more accurate diagnostic options for patients. While currently limited to the study cohort, successful validation could eventually influence clinical imaging standards.
The takeaway
The study highlights how rapid-manufacture radiotracers are becoming a focus for improving diagnostic sensitivity. Patients and providers should watch for future results to see if this agent outperforms the 18F-based tracers currently used in standard clinical settings.
What happens next
Nuclidium anticipates conducting multiple clinical trials over the coming months to continue evaluating its theranostic program.
Further reading
Learn more about the latest developments in Cancer treatment and diagnostic research.
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