title: Detection of pulmonary emboli with 99mTc-labeled anti-D-dimer (DI-80B3)Fab' fragments (ThromboView).
abstract: BACKGROUND
  We report a new method to diagnose acute pulmonary embolism (PE) 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 PE in patients for whom other methods are nondiagnostic or contraindicated.
  
  
  OBJECTIVE
  We performed a prospective, multicenter study to investigate the sensitivity and specificity of (99m)Tc-DI-80B3/SPECT in patients with suspected acute PE.
  
  
  METHODS
  Subjects with a moderate to high clinical probability of PE or a positive D-dimer test underwent a PE-protocol contrast-enhanced multidetector thoracic computed tomography (CT) scan as well as (99m)Tc-DI-80B3/SPECT (0.5 mg (99m)Tc-DI-80B3 intravenously followed by a thoracic SPECT 2.5 h later). Separate and independent adjudication committees, blinded to clinical data and other test results, interpreted the (99m)Tc-DI-80B3/SPECT scans (PE detected as foci of abnormally increased (99m)Tc uptake) and the thoracic CT scans using Prospective Investigation of Pulmonary Embolism Diagnosis 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 scan) there were 21 patients with PE and 21 without. (99m)Tc-DI-80B3/SPECT had a sensitivity of 76.2% (95% confidence interval, 52.8-91.8%) and a specificity of 90.5% (95% confidence interval, 69.8-98.8%). Treatment-related serious adverse events did not occur.
  
  
  CONCLUSIONS
  (99m)Tc-DI-80B3/SPECT was sensitive and specific for acute PE in subjects with moderate to high clinical probability of PE or a positive D-dimer test. (99m)Tc-DI-80B3/SPECT demonstrated an acceptable safety profile and avoids exposure to contrast.
authors.affiliation: University of California, San Diego Medical Center, 200 West Arbor Drive, San Diego, CA 92103-8378, USA. t1morris@ucsd.edu
authors.forename: Timothy A
authors.initials: TA
authors.lastname: Morris
authors.forename: Michael
authors.initials: M
authors.lastname: Gerometta
authors.forename: Roger D
authors.initials: RD
authors.lastname: Yusen
authors.forename: Richard H
authors.initials: RH
authors.lastname: White
authors.forename: James D
authors.initials: JD
authors.lastname: Douketis
authors.forename: Scott
authors.initials: S
authors.lastname: Kaatz
authors.forename: Richard C
authors.initials: RC
authors.lastname: Smart
authors.forename: David
authors.initials: D
authors.lastname: Macfarlane
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Ginsberg
mesh_terms: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D003287:Contrast Media; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D061330:Multidetector Computed Tomography / Q000379:methods; D015588:Observer Variation; D015609:Organotechnetium Compounds; D011446:Prospective Studies; D011655:Pulmonary Embolism / Q000000981:diagnostic imaging*; D011856:Radiographic Image Enhancement / Q000379:methods; D019275:Radiopharmaceuticals; D012680:Sensitivity and Specificity; D015899:Tomography, Emission-Computed, Single-Photon / Q000379:methods*
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D003287:Contrast Media; D015609:Organotechnetium Compounds; D019275:Radiopharmaceuticals; C515867:thromboview