Sodium fluoride F-18

Sodium fluoride F-18 is one of the oldest PET radiopharmaceuticals: it was first approved by FDA in 1972 (NDA 17-042, held by the predecessor of GE Healthcare) as a bone-imaging agent, then re-approved under a newer label format in 2011 (NDA 22-494, sponsor National Cancer Institute) after the original product had lapsed commercially. Both approvals cover PET imaging of bone to define areas of altered osteogenic activity; neither approval is oncology-specific, but the agent's principal modern use is detecting osteoblastic bone metastases, most often from prostate and breast cancer, where it offers higher sensitivity and better spatial resolution than technetium-99m bone scintigraphy.

The recommended adult dose is 300-450 MBq (8-12 mCi) intravenously, with imaging optimally at one to two hours; no adverse reactions have been established in the FDA label, and the main safety statement concerns cumulative radiation exposure rather than a pharmacological toxicity. Because uptake is a marker of bone turnover, not malignancy, degenerative disease, fracture healing and other benign remodelling can be false positives, and correlation with CT or MRI is standard practice.