Calciphylaxis is a rare vascular calcification syndrome
mainly affecting end-stage kidney disease patients on dialysis. It causes blockage
of small dermal and subcutaneous branches of arteries, resulting in painful
necrotic skin ulcers, and has a 30 50 percent one-year mortality rate. Early
diagnosis is difficult, and nearly 75 percent of patients are initially
misdiagnosed.
"The current standard for calciphylaxis diagnosis is skin
biopsy, however it is invasive and has limited sensitivity of just over 50
percent," said Haj-Mirzaian. "Not only do biopsies have poor diagnostic
reliability, but delayed or missed diagnosis prevents timely intervention,
resulting in high morbidity and mortality."
In the study, researchers will address the need for
non-invasive diagnosis and monitoring of calciphylaxis burden by evaluating the
efficacy of 18F-NaF PET/CT as a molecular imaging biomarker in
high-risk dialysis patients. The prospective, clinical study will utilize three
groups: dialysis-dependent patients suspected of calciphylaxis, high-risk dialysis-dependent
patients without suspicion, and lower-risk controls. All will undergo 18F-NaF
PET/CT imaging, and findings will be compared to a strict reference standard including
clinical review, skin biopsy (if available), and outcomes.
According to Heidari, "Early, accurate diagnosis with 18F-NaF
PET/CT could enable timely interventions like wound care, sodium thiosulfate
treatment, and stopping triggering agents such as warfarin to prevent tissue
necrosis. As a clinical tool for calciphylaxis, 18F-NaF PET/CT has
the potential to shift diagnosis from end-stage to early, minimally invasive
molecular detection, potentially reducing misdiagnosis and mortality."