Optimizing Protocols for the Individual Patient in CT Pulmonary Angiography.

Pulmonary Embolism Clinical Trial

— OptIPeCT  

Official title:

Optimizing Tube Voltage Settings and Injection Parameters for the Individual Patient in CT Pulmonary Angiography.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02611115
• Other study ID #: 15-4-167
• Status: Completed
• Phase: N/A
• First received: November 17, 2015
• Last updated: October 4, 2017
• Start date: September 2015
• Est. completion date: December 2016

Study information

• Verified date: October 2017
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Computed tomographic pulmonary angiography (CTPA) is considered the gold standard for the diagnosis of pulmonary embolism (PE). PE is a potentially fatal disease in which a thrombus is lodged into a pulmonary artery blocking blood flow and potentially leading to respiratory distress, acute right cardiac failure or death. Therefore early and correct diagnosis is crucial.

The diagnostic and clinical value of CTPA has already been firmly substantiated. Unfortunately up to 7.3% of PE scans are still deemed to be non-diagnostic, for example due to insufficient contrast enhancement in the target arteries.

Therefore future research should focus on two important aspects of CT imaging. On the one hand optimal enhancement for the individual patient, on the other hand preventing additional risk of CT imaging - namely contrast induced nephropathy (CIN) and radiation risk. Thus the purpose of our study will be to optimize radiation dose settings (e.g. tube voltage, tube current) and CM application for the individual patient in CTPA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Suspicion of pulmonary embolism

Exclusion Criteria:

• Severe allergy against Iopromide or any of the ingredients, previous severe CM reaction (according to current ESUR guidelines), renal insufficiency, pregnancy

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Bayer

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Image quality	Evaluation of subjective and objective image quality based on individualized CTPA protocols	one year
Secondary	Reduction of radiation dose	Effect of individualized tube voltage settings on radiation	one year