Detection of Pulmonary Emboli With 99mTc-Labeled Anti-D-dimer (DI-80B3)Fab' Fragments (ThromboView).
Am J Respir Crit Care Med. 2011 Jun 16;
Authors: Morris TA, Gerometta M, Yusen RD, White RH, Douketis JD, Kaatz S, Smart RC, Macfarlane D, Ginsberg JS
RATIONALE: We report a new method to diagnose acute pulmonary embolism by single photon emission computerized tomography (SPECT) after administration of (99m)Tc-labeled anti-D-dimer (DI-80B3) monoclonal antibody Fab' fragments. This novel technique provides an additional approach to diagnosing pulmonary embolism in patients for whom other methods are non-diagnostic or contraindicated. OBJECTIVES: We performed a prospective, multicenter study to investigate the sensitivity and specificity of (99m)Tc-DI-80B3/SPECT in patients with suspected acute pulmonary embolism. METHODS: Subjects with a moderate to high clinical probability of pulmonary embolism or a positive D-dimer test underwent a PE-protocol contrast-enhanced multidetector thoracic CT as well as (99m)Tc-DI-80B3/SPECT (0.5 mg (99m)Tc-DI-80B3 intravenously followed by a thoracic SPECT 2.5 hours later). Separate and independent adjudication committees, blinded to clinical data and other test results, interpreted the (99m)Tc-DI-80B3/SPECT scans (pulmonary embolism detected as foci of abnormally increased (99m)Tc uptake) and the thoracic CT scans using PIOPED II criteria. RESULTS: Of the 52 patients who were enrolled and completed both tests, 42 had both evaluable SPECT scans and thoracic CT scans. Using the criterion standard (thoracic CT) there were 21 patients with pulmonary embolism and 21 without. (99m)Tc-DI-80B3/SPECT had a sensitivity of 76.2% (95% CI 52.8% to 91.8%) and a specificity of 90.5% (95% CI 69.8% to 98.8%). Treatment-related serious adverse events did not occur. CONCLUSIONS: (99m)Tc-DI-80B3/SPECT was sensitive and specific for acute pulmonary embolism in subjects with moderate to high clinical probability of pulmonary embolism or a positive D-dimer test. (99m)Tc-DI-80B3/SPECT demonstrated an acceptable safety profile and avoids exposure to contrast.().
PMID: 21680946 [PubMed - as supplied by publisher]