The move from accuracy studies to randomized trials in PET: current status and future directions

Area of Science:

• Nuclear Medicine
• Diagnostic Imaging
• Clinical Trials

Background:

• Diagnostic randomized controlled trials (RCTs) investigating Positron Emission Tomography (PET) benefits have increased since 2002.
• These studies are crucial for informing guideline developers and policymakers.
• The nuclear medicine community is transitioning from accuracy studies to RCTs for PET evaluation.

Purpose of the Study:

• To assess the progress of the nuclear medicine community in conducting PET diagnostic RCTs.
• To identify key issues for planning future PET RCTs.
• To evaluate the quality and sufficiency of current PET RCTs for demonstrating clinical benefit.

Main Methods:

• Systematic review of diagnostic RCTs involving PET in one arm.
• Inclusion of published, registered unpublished, and planned studies.
• Assessment of quality indicators: patient-important outcomes, sample size, and comparator.

Main Results:

• 14 published and 15 planned studies were identified.
• Many studies lacked patient-important outcomes (5/14 published, 12/15 planned).
• Sample sizes were frequently insufficient to detect significant results; comparators generally reflected current standards.

Conclusions:

• Current PET RCTs are insufficient for evidence-based decisions on clinical benefit in primary diagnosis, staging, and follow-up.
• Accuracy studies may still be needed to infer clinical benefit in traditional areas.
• Improving patient-important outcomes and sample sizes is critical for future PET RCTs, especially in treatment planning and response evaluation.