Prospective exploratory pilot study of 18 F-FMISO PET/CT for assessing tumor hypoxia in soft tissue sarcomas
Abstract
Hypoxia is associated with poor outcomes in soft tissue sarcoma (STS) and is linked to increased expression of hypoxia-inducible factor 1-alpha (HIF-1α), carbonic anhydrase IX (CAIX), and lysyl hydroxylase 2 (PLOD2). These factors are potential therapeutic targets. This exploratory study aimed to investigate the correlation between 18F-fluoromisonidazole (18F-FMISO) positron emission tomography (PET) imaging, a marker of hypoxia, and the expression of these biomarkers in STS. This imaging phase II clinical trial (NCT #03730077) recruited 5 patients with suspected soft tissue sarcoma (STS) and imaged these patients with 18F-Fluorodeoxyglucose (18F-FDG) and 18F-FMISO within 2 weeks of each other. STS tissue was analyzed for HIF-1α, CAIX, and PLOD2 expression using immunohistochemistry and western blotting. Collagen formation was assessed by Masson's trichrome. In this small sample, a correlation was found between STS size and PLOD2 expression (r = 0.996, P = 0.004). STS grade correlated positively with 18F-FMISO T/M (tumor/muscle) SUVmax (r = 0.894, P = 0.041). 18F-FDG correlated positively with 18F-FMISO SUVmax (r = 0.994, P = 0.006). Positive but non-significant associations were noted between 18F-FMISO T/M SUVmax and CAIX (r = 0.95, P > 0.05) and PLOD2 (r = 0.93, P > 0.05). These preliminary observations in a small sample are hypothesis-generating at best and must be interpreted with substantial caution due to the extremely limited number of patients, which precludes robust…
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Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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