Pulmonary Embolism Clinical Trial
— InSPECT-DECTOfficial title:
Iodine Mapping Using Subtraction in Pulmonary Embolism Computed Tomography Versus Dual Energy Computed Tomography
Verified date | September 2017 |
Source | Radboud University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Comparing two techniques (Subtraction and Dual Energy CT) for functional Chest CT for patients with suspected with pulmonary embolism.
Status | Completed |
Enrollment | 295 |
Est. completion date | October 30, 2017 |
Est. primary completion date | October 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years and older |
Eligibility |
Inclusion Criteria: - Patients 35 years or older and able to provide informed consent - Clinically requested CTPA because of suspected pulmonary embolism - Available history and physical examination. Exclusion Criteria: - Pregnancy - Hemodynamic instability - Uncooperative patients. - Contra-indication to intravenous iodine administration. - Inability to position the arms above the shoulders |
Country | Name | City | State |
---|---|---|---|
Netherlands | Radboudumc | Nijmegen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Radboud University |
Netherlands,
Deak PD, Smal Y, Kalender WA. Multisection CT protocols: sex- and age-specific conversion factors used to determine effective dose from dose-length product. Radiology. 2010 Oct;257(1):158-66. doi: 10.1148/radiol.10100047. — View Citation
Lu GM, Zhao Y, Zhang LJ, Schoepf UJ. Dual-energy CT of the lung. AJR Am J Roentgenol. 2012 Nov;199(5 Suppl):S40-53. doi: 10.2214/AJR.12.9112. Review. — View Citation
Mayo J, Thakur Y. Pulmonary CT angiography as first-line imaging for PE: image quality and radiation dose considerations. AJR Am J Roentgenol. 2013 Mar;200(3):522-8. doi: 10.2214/AJR.12.9928. Review. — View Citation
Pontana F, Faivre JB, Remy-Jardin M, Flohr T, Schmidt B, Tacelli N, Pansini V, Remy J. Lung perfusion with dual-energy multidetector-row CT (MDCT): feasibility for the evaluation of acute pulmonary embolism in 117 consecutive patients. Acad Radiol. 2008 Dec;15(12):1494-504. doi: 10.1016/j.acra.2008.05.018. — View Citation
Remy-Jardin M, Pistolesi M, Goodman LR, Gefter WB, Gottschalk A, Mayo JR, Sostman HD. Management of suspected acute pulmonary embolism in the era of CT angiography: a statement from the Fleischner Society. Radiology. 2007 Nov;245(2):315-29. Epub 2007 Sep 11. Review. — View Citation
van der Molen AJ, Schilham A, Stoop P, Prokop M, Geleijns J. A national survey on radiation dose in CT in The Netherlands. Insights Imaging. 2013 Jun;4(3):383-90. doi: 10.1007/s13244-013-0253-9. Epub 2013 May 15. — View Citation
Wildberger JE, Klotz E, Ditt H, Mahnken AH, Spüntrup E, Günther RW. Multi-slice CT for visualization of acute pulmonary embolism: single breath-hold subtraction technique. Rofo. 2005 Jan;177(1):17-23. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence of perfusion defects as reference standard | After 1.5 year, the radiologists scores the presence of perfusion defects caused by pulmonary embolism as a reference standard. | 1.5 year | |
Secondary | Radiation dose | Through study completion, an average of 2 months | ||
Secondary | Clinical diagnosis of Pulmonary embolism: after 6 months follow-up | Through study completion, after the first inclusion, the patients are followed for half a year. | ||
Secondary | 30-day all cause mortality and PE-associated mortality | Through study completion, an average of three months | ||
Secondary | 6 months all cause mortality and PE-associated mortality | Through study completion, an average of three months |
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