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Theranostics in Nuclear Medicine: Historical, Regulatory, and Evidence Context for the Practicing Nuclear Medicine
Deepak Behera1, Alexander McEwan2
1The Bracken Group, Newtown PA, USA; Adaptive Research, San Francisco, CA, USA.
Abstract:
Theranostic radiopharmaceutical therapy has moved from niche practice to mainstream oncology, anchored by approvals of lutetium Lu 177 dotatate for somatostatin receptor-positive neuroendocrine tumors and lutetium Lu 177 vipivotide tetraxetan for PSMA-positive prostate cancer. Yet the field's future depends on rigorous clinical trial design, realistic operational planning, and workforce readiness. This review summarizes how theranostics evolved, outlines current regulatory and trial-design yardsticks (including dose optimization and expectations for assessment of late-toxicity), and provides a practical framework for nuclear medicine physicians to assess protocols and prepare their practices for expanding indications and combinations.
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