Comparison of Post-injection Site Pain Between Technetium Sulfur Colloid and Technetium Tilmanocept in Breast Cancer Patients Undergoing Sentinel Lymph Node Biopsy

Abstract

Background No prior studies have examined injection pain associated with Technetium-99m Tilmanocept (TcTM).MethodsThis was a randomized, double-blinded study comparing postinjection site pain between filtered Technetium Sulfur Colloid (fTcSC) and TcTM in breast cancer lymphoscintigraphy. Pain was evaluated with a visual analogue scale (VAS) (0–100 mm) and the short-form McGill Pain Questionnaire (SF-MPQ). The primary endpoint was mean difference in VAS scores at 1-min postinjection between fTcSC and TcTM. Secondary endpoints included a comparison of SF-MPQ scores between the groups at 5 min postinjection and construction of a linear mixed effects model to evaluate the changes in pain during the 5-min postinjection period.ResultsFifty-two patients underwent injection (27-fTcSC, 25-TcTM). At 1-min postinjection, patients who received fTcSC experienced a mean change in pain of 16.8 mm (standard deviation (SD) 19.5) compared with 0.2 mm (SD 7.3) in TcTM (p = 0.0002). At 5 min postinjection, the mean total score on the SF-MPQ was 2.8 (SD 3.0) for fTcSC versus 2.1 (SD 2.5) for TcTM (p = 0.36). In the mixed effects model, injection agent (p < 0.001), time (p < 0.001) and their interaction (p < 0.001) were associated with change in pain during the 5-min postinjection period. The model found fTcSC resulted in significantly more pain of 15.2 mm (p < 0.001), 11.3 mm (p = 0.001), and 7.5 mm (p = 0.013) at 1, 2, and 3 min postinjection, respectively.ConclusionsInjection with fTcSC causes significantly more pain during the first 3 min postinjection compared with TcTM in women undergoing lymphoscintigraphy for breast cancer.

Tc‐99m tilmanocept versus Tc‐99m sulfur colloid in breast cancer sentinel lymph node identification: Results from a randomized, blinded clinical trial

“…Controlling for probability of a type 1 error, (a) = 0.01 and power (1 − b) = 0.9, 52 total patients (26 per group) were needed to detect no difference in pain between groups at 1 min. The study ended after 52 total patients received radiopharmaceutical injection . To compare surgical performance between the two agents, the number of removed surgical lymph nodes was compared between groups using t‐test.…”

“…Female patients, aged >18 years with a diagnosis of primary breast cancer or ductal carcinoma in situ (DCIS) with planned SLN biopsy as part of the surgical plan were approached at preoperative clinic visits of the principal investigator (AMW). Pregnant patients, patients undergoing bilateral SLN biopsy, or patients with clinical and/or radiological evidence of metastatic lymph nodes or systemic disease were excluded …”

“…After a patient consented to the study, the Clinical Trials Office (CTO) assigned a study number to the patient corresponding to either of the two groups. The CTO facilitated ordering of the proper agent for injection with the nuclear medicine technician such that both the radiologist and the operating team were blinded to the radiopharmaceutical agent injected …”

“…Currently, there are no prior prospective studies comparing SLN identification outcomes between TcSC and TcTM. Our institution previously conducted a randomized, double‐blinded controlled clinical trial comparing post‐injection site pain between TcTM and TcSC . In that trial, patients receiving an injection of TcSC experienced significantly more pain 3 mins after injection compared with TcTM .…”

“…Our institution previously conducted a randomized, double‐blinded controlled clinical trial comparing post‐injection site pain between TcTM and TcSC . In that trial, patients receiving an injection of TcSC experienced significantly more pain 3 mins after injection compared with TcTM . Given the significant difference in side effects and mechanism, it is important to compare technical outcomes between the two agents.…”