The Scientific and Clinical Case for Reviewing Diagnostic Radiopharmaceutical Extravasation Long-Standing Assumptions

Area of Science:

• Nuclear Medicine
• Radiopharmaceutical Therapy
• Radiation Safety

Background:

• Diagnostic nuclear medicine procedures offer significant patient benefit, but radiopharmaceutical extravasation can compromise outcomes.
• Prevailing hypotheses suggest extravasations are harmless, deliver low doses, and require complex dosimetry.
• This study challenges these assumptions by evaluating current knowledge and original research.

Purpose of the Study:

• To test the hypotheses that diagnostic radiopharmaceutical extravasations do not cause harm, do not result in high absorbed doses, and require complex dosimetry.
• To evaluate the impact of extravasation on diagnostic accuracy and patient management.
• To assess the absorbed radiation dose to tissues following extravasation.

Main Methods:

• Comprehensive literature review of 58 peer-reviewed documents.
• Analysis of 38 adverse event reports involving diagnostic radiopharmaceutical extravasation.
• Clinical case review of five patients with extravasation, including repeat imaging and dosimetry.
• Dosimetry calculations for extravasated tissue volumes and skin surface.

Main Results:

• Literature review and adverse event reports indicate potential patient harm from extravasation.
• Clinical cases showed misidentified lesions, underestimated Standardized Uptake Values (SUVs) (19-73%), non-diagnostic scans, and repeat imaging needs.
• Dosimetry revealed significant absorbed doses to tissue (1.1-8.7 Gy) and skin (up to 4.2 Sv).

Conclusions:

• Significant extravasations can cause patient harm and deliver radiation doses exceeding reporting limits and deterministic effect thresholds.
• Monitoring diagnostic radiopharmaceutical injections and performing dosimetry in specific cases are crucial.
• Implementing process improvements to minimize extravasation frequency is essential for nuclear medicine safety.