Study Confirms Minimal Risk from Extravasation in Lu-177 DOTATATE Cancer Therapy

Accidental extravasation during the administration of lutetium-177 (Lu-177) DOTATATE therapy has little to no effect on treatment safety or efficacy in cancer patients, according to a new study from Memorial Sloan Kettering Cancer Center.

The findings support current administration protocols for Lu-177 DOTATATE (Lutathera, Novartis), a targeted radiopharmaceutical therapy for neuroendocrine tumors, and suggest that even when extravasation occurs—where a portion of the radiopharmaceutical leaks into surrounding tissue—the clinical risk remains minimal.

“Extravasation of radiopharmaceuticals raises potential concerns, including adverse tissue reactions and reduction in both quantitative accuracy and therapeutic efficacy,” wrote lead author Gunjan Kayal, PhD, and colleagues. The research was published June 26 in the Journal of Nuclear Medicine.

To assess the frequency and effects of extravasation, the researchers reviewed 1,314 Lu-177 DOTATATE infusions administered to 365 patients between May 2017 and April 2024. Each infusion was performed via slow intravenous delivery using a pump, followed by whole-body imaging three to four hours later to check for radiopharmaceutical distribution and possible leakage at the infusion site.

Of the 1,314 treatments, only 14 (1.1%) showed signs of extravasation, identified by a focal increase in uptake at the injection site. Most patients in these cases reported only mild discomfort, and no visible swelling or complications were observed.

Importantly, the amount of radiopharmaceutical retained at the injection site was minimal—less than 1% of the total dose, and less than 2.1% of whole-body activity. In terms of absorbed radiation, the median dose at the injection site was 0.53 Gy, with a maximum of 1.23 Gy—levels well below thresholds for skin damage.

“We found no patients retained more than 1% of the injected activity at the infusion site at the time of scanning, and no adverse events, including local cutaneous tissue damage or deterministic radiogenic skin injuries, were reported, either immediately or in the subsequent days or weeks,” the authors noted.

The study highlights the importance of best practices in administration—including controlled infusion using a Graseby pump, careful verification of needle placement, and continuous monitoring during delivery. The authors also underscored the value of early imaging to detect any inadvertent extravasation.

“Early imaging after therapy is critical in identifying patients at potential risk of local radiotoxicity resulting from theranostic infiltrations, indicating its importance in patient care management,” they concluded.

Overall, the research provides reassuring evidence that extravasation during Lu-177 DOTATATE treatment is rare and does not compromise patient safety or therapeutic outcomes when proper procedures are followed.