Clinical trial NCT05879380: MR Pulmonary Angiography to Replace CT Pulmonary Angiography for Patients With a Suspicion of a Pulmonary Embolism
Official title: MR Pulmonary Angiography to Replace CT Pulmonary Angiography for Patients With a Suspicion of a Pulmonary Embolism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Embolism
Radiation Exposure
Lead sponsor: Noordwest Ziekenhuisgroep
Sponsor class: OTHER
Collaborators: name: Leiden University Medical Center
First posted: 2023-05-30
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient population consists of all patients with a suspicion of pulmonary embolisms on all departments of our hospital - including ER, wards, primary lung-heart aid ward - who undergo a CTPA during the study period.

Brief summary: Rational: The first choice of imaging modality for patients with a suspicion of pulmonary embolism is CT pulmonary angiography (CTPA). Our goal is to avoid extra cases of cancer due to the carcinogenic effect of ionizing radiation from using CTPA. This carcinogenic effect is greatest in women under 40. In the Netherlands, at least 100,000 CTPA's are performed each year, 10% of which are in women under 40 years old, resulting in at least 10 extra tumors induced per year. The goal is to investigate whether MR Pulmonary angiography (MRPA) can serve as an alternative to CTPA. If it can replace CTPA, this will result in a significant health benefit.

Objective: the primary objective is to determine the sensitivity and specificity of MR Pulmonary Angiography (MRPA) with CT Pulmonary Angiography (CTPA) as the gold standard.

Secondary outcomes: to determine the clinical applicability of MRPA in daily practice, negative predictive value, positive predictive value, accuracy of MRPA (compared to CTPA), and agreement in assessment between radiologists.

Study design: observational-prospective diagnostic study, an additional MRPA will be performed in patients with a suspicion of pulmonary embolism.

Study population: in patients with clinical suspicion of pulmonary embolism, a standard CTPA is made for exclusion or confirmation of the disease. The study population will consist of 272 patients.

Primary outcome parameters: determining the sensitivity and specificity of MRPA compared to CTPA (gold standard) in patients with a (clinical) suspicion of pulmonary embolism.

Secondary outcome parameters: Determining the negative predictive value, positive predictive value, accuracy, inter-observer agreement with respect to MRPA, and applicability in daily clinical practice.


Eligibility criteria: Inclusion Criteria:

* Mentally competent
* 18 years old

Exclusion Criteria:

* Regular exclusion criteria for MR examination,
* Contrast allergy,
* Hemodynamic instability,
* Severe respiratory insufficiency
* Immobile patient.
* Pregnancy
* Dialysis patients
* COVID-19 positive patients

Primary outcomes:
measure: Sensitivity
timeFrame: At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months
measure: Specificity
timeFrame: At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months
Secondary outcomes:
measure: To determine the negative predictive value of MRPA
timeFrame: At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months
measure: To determine the positive predictive value of MRPA
timeFrame: At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months
measure: To determine the accuracy of MRPA
timeFrame: At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months
measure: To determine the inter-observer agreement / variability of MRPA
timeFrame: At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months
measure: To determine the feasibility in daily clinical practice of MRPA
timeFrame: At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months
Other outcomes:
Locations:
Study officials:
affiliation: Noordwest Ziekenhuisgroep
name: Remy Geenen
role: STUDY_CHAIR
References: