Iodine Mapping Using Subtraction in Pulmonary Embolism CT Versus Dual-Energy CT

NCT02890706 | Completed

• 1 other identifier: NL56542.091.16
• Study Type: interventional
• Target: 295
• Locations: 1 country
• Sites: 1

Brief Summary

Comparing two techniques (Subtraction and Dual Energy CT) for functional Chest CT for patients with suspected with pulmonary embolism.

Conditions

Pulmonary Embolism

Keywords

Pulmonary embolism (PE); Dual-Energy CT (DECT); Subtraction imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Radiation dose

  Through study completion, an average of 2 months

• 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.

• 30-day all cause mortality and PE-associated mortality

  Through study completion, an average of three months

• 6 months all cause mortality and PE-associated mortality

  Through study completion, an average of three months

Study Arms (1)

Patients

OTHER

Each patient undergo the same CT protocol. Theobservers will observe the detection of the perfusion defects in two different techniques.

Device: Iodine Mapping using Subtraction in Pulmonary Embolism Computed Tomography versus Dual Energy Computed Tomography

Interventions

Iodine Mapping using Subtraction in Pulmonary Embolism Computed Tomography versus Dual Energy Computed Tomography DEVICE

Compare two techniques of the CT scanner

Patients

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 35 years or older and able to provide informed consent
• Clinically requested CTPA because of suspected pulmonary embolism
• Available history and physical examination.

You may not qualify if:

• Pregnancy
• Hemodynamic instability
• Uncooperative patients.
• Contra-indication to intravenous iodine administration.
• Inability to position the arms above the shoulders

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6500, Netherlands

Location

Related Publications (8)

• 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.

  PMID: 20851940 BACKGROUND

• 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.

  PMID: 23673455 BACKGROUND

• 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. doi: 10.1148/radiol.2452070397. Epub 2007 Sep 11. No abstract available.

  PMID: 17848685 BACKGROUND

• 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.

  PMID: 23097167 BACKGROUND

• Wildberger JE, Klotz E, Ditt H, Mahnken AH, Spuntrup E, Gunther RW. Multi-slice CT for visualization of acute pulmonary embolism: single breath-hold subtraction technique. Rofo. 2005 Jan;177(1):17-23. doi: 10.1055/s-2004-813875.

  PMID: 15657816 BACKGROUND

• 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.

  PMID: 23436840 BACKGROUND

• 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.

  PMID: 19000866 BACKGROUND

• Grob D, Smit E, Prince J, Kist J, Stoger L, Geurts B, Snoeren MM, van Dijk R, Oostveen LJ, Prokop M, Schaefer-Prokop CM, Sechopoulos I, Brink M. Iodine Maps from Subtraction CT or Dual-Energy CT to Detect Pulmonary Emboli with CT Angiography: A Multiple-Observer Study. Radiology. 2019 Jul;292(1):197-205. doi: 10.1148/radiol.2019182666. Epub 2019 May 14.

  PMID: 31084482 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Monique Brink, MD

  Radboud University Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: September 7, 2016
• Study Start: July 7, 2016
• Primary Completion: October 30, 2017
• Study Completion: October 30, 2017
• Last Updated: November 7, 2017

Record last verified: 2017-09

Locations

NL (1)