CTEPH DIAGNOSIS Europe - MRI

CHANGE-MRI (CTEPH DIAGNOSIS Europe - MRI)

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02791282

Enrollment

1080

Registered

2016-06-06

Start date

2016-05-31

Completion date

2020-06-30

Last updated

2016-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

Keywords

Chronic Thromboembolic Pulmonary Hypertension (CTEPH), MRI, SPECT

Brief summary

Phase III diagnostic trial to demonstrate that functional lung MRI can replace VQ-SPECT in a diagnostic strategy for patients with suspected CTEPH where positive findings are verified with catheter pulmonary angiography (CPA), or computed tomography pulmonary angiography (CTPA)

Detailed description

CHANGE-MRI is a prospective, multicentre, comparative phase III diagnostic study. The study aims to show via an in-place validation that MRI can replace VQ-SPECT as a screening test for chronic pulmonary embolism in the diagnostic algorithm for CTEPH. The diagnostic gold standard is catheter pulmonary angiography (CPA) or computed tomography pulmonary angiography (CTPA) with correction from the clinical outcome after 6-12 months.

Interventions

OTHERIndex test: functional dynamic contrast enhanced (DCE)-MRI

Index test: functional dynamic contrast enhanced (DCE)-MRI Reference test: Ventilation-perfusion (VQ) single-photon emission computed tomography (SPECT) Follow-up per patient: clinical assessment after 6-12 months

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Transthoracic echocardiography indicates pulmonary hypertension * Patients with clinical suspicion for CTEPH, scheduled for SPECT * Provided informed consent for the study * Age \>18y

Exclusion criteria

* Patient unable to undergo MRI (e.g. due to claustrophobia, cardiac pacemaker, hypersensitivity to MR i.v. contrast imaging agents) * Women who are pregnant or breast feeding

Design outcomes

Primary

Measure	Time frame
The proportion of patients with positive MRI in the group of patients who have a positive VQ-SPECT diagnosis for chronic pulmonary embolism and who are positive in the gold standard	6 months
The proportion of patients with positive MRI in the group of patients with negative VQ-SPECT who are negative in the gold standard	6 months

Countries

Germany

Contacts

Primary ContactJens Vogel-Claussen, MD

vogel-claussen.jens@mh-hannover.de+49 511 5323421

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026