Detection of pulmonary emboli with 99mTc-labeled anti-D-dimer (DI-80B3)Fab′ fragments (ThromboView)

Timothy A. Morris, Michael Gerometta, Roger D. Yusen, Richard H White, James D. Douketis, Scott Kaatz, Richard C. Smart, David Macfarlane, Jeffrey S. Ginsberg

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

Rationale: We report a new method to diagnose acute pulmonary embolism (PE) by single photon emission computerized tomography (SPECT) after administration of 99mTc-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. Objectives:We performed a prospective, multicenter study to investigate the sensitivity and specificity of 99mTc-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 contrastenhanced multidetector thoracic computed tomography (CT) scan as well as 99mTc-DI-80B3/SPECT (0.5 mg 99mTc-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 99mTc-DI-80B3/SPECT scans (PE detected as foci of abnormally increased 99mTc uptake) and the thoracic CT scans using Prospective Investigation of Pulmonary Embolism Diagnosis II criteria. Measurements and Main 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. 99mTc-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: 99mTc-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. 99mTc-DI-80B3/SPECT demonstrated an acceptable safety profile and avoids exposure to contrast. Clinical trial NCT00519506 registered with www.clinicaltrials.gov.

Original languageEnglish (US)
Pages (from-to)708-714
Number of pages7
JournalAmerican Journal of Respiratory and Critical Care Medicine
Volume184
Issue number6
DOIs
StatePublished - Sep 15 2011

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Immunoglobulin Fab Fragments
Embolism
Pulmonary Embolism
Single-Photon Emission-Computed Tomography
Lung
Thorax
Tomography
RHO(D) antibody
fibrin fragment D
thromboview
Confidence Intervals
Immunoglobulin Fragments
Multidetector Computed Tomography
Multicenter Studies
Monoclonal Antibodies
Clinical Trials
Prospective Studies
Safety
Sensitivity and Specificity

Keywords

  • Pulmonary embolism
  • Radioimmunoimaging
  • Sensitivity and specificity
  • Single photon emission computerized tomography

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Critical Care and Intensive Care Medicine

Cite this

Detection of pulmonary emboli with 99mTc-labeled anti-D-dimer (DI-80B3)Fab′ fragments (ThromboView). / Morris, Timothy A.; Gerometta, Michael; Yusen, Roger D.; White, Richard H; Douketis, James D.; Kaatz, Scott; Smart, Richard C.; Macfarlane, David; Ginsberg, Jeffrey S.

In: American Journal of Respiratory and Critical Care Medicine, Vol. 184, No. 6, 15.09.2011, p. 708-714.

Research output: Contribution to journalArticle

Morris, TA, Gerometta, M, Yusen, RD, White, RH, Douketis, JD, Kaatz, S, Smart, RC, Macfarlane, D & Ginsberg, JS 2011, 'Detection of pulmonary emboli with 99mTc-labeled anti-D-dimer (DI-80B3)Fab′ fragments (ThromboView)', American Journal of Respiratory and Critical Care Medicine, vol. 184, no. 6, pp. 708-714. https://doi.org/10.1164/rccm.201104-0624OC
Morris, Timothy A. ; Gerometta, Michael ; Yusen, Roger D. ; White, Richard H ; Douketis, James D. ; Kaatz, Scott ; Smart, Richard C. ; Macfarlane, David ; Ginsberg, Jeffrey S. / Detection of pulmonary emboli with 99mTc-labeled anti-D-dimer (DI-80B3)Fab′ fragments (ThromboView). In: American Journal of Respiratory and Critical Care Medicine. 2011 ; Vol. 184, No. 6. pp. 708-714.
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abstract = "Rationale: We report a new method to diagnose acute pulmonary embolism (PE) by single photon emission computerized tomography (SPECT) after administration of 99mTc-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. Objectives:We performed a prospective, multicenter study to investigate the sensitivity and specificity of 99mTc-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 contrastenhanced multidetector thoracic computed tomography (CT) scan as well as 99mTc-DI-80B3/SPECT (0.5 mg 99mTc-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 99mTc-DI-80B3/SPECT scans (PE detected as foci of abnormally increased 99mTc uptake) and the thoracic CT scans using Prospective Investigation of Pulmonary Embolism Diagnosis II criteria. Measurements and Main 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. 99mTc-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: 99mTc-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. 99mTc-DI-80B3/SPECT demonstrated an acceptable safety profile and avoids exposure to contrast. Clinical trial NCT00519506 registered with www.clinicaltrials.gov.",
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AU - Yusen, Roger D.

AU - White, Richard H

AU - Douketis, James D.

AU - Kaatz, Scott

AU - Smart, Richard C.

AU - Macfarlane, David

AU - Ginsberg, Jeffrey S.

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N2 - Rationale: We report a new method to diagnose acute pulmonary embolism (PE) by single photon emission computerized tomography (SPECT) after administration of 99mTc-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. Objectives:We performed a prospective, multicenter study to investigate the sensitivity and specificity of 99mTc-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 contrastenhanced multidetector thoracic computed tomography (CT) scan as well as 99mTc-DI-80B3/SPECT (0.5 mg 99mTc-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 99mTc-DI-80B3/SPECT scans (PE detected as foci of abnormally increased 99mTc uptake) and the thoracic CT scans using Prospective Investigation of Pulmonary Embolism Diagnosis II criteria. Measurements and Main 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. 99mTc-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: 99mTc-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. 99mTc-DI-80B3/SPECT demonstrated an acceptable safety profile and avoids exposure to contrast. Clinical trial NCT00519506 registered with www.clinicaltrials.gov.

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KW - Radioimmunoimaging

KW - Sensitivity and specificity

KW - Single photon emission computerized tomography

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