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CTEPH DIAGNOSIS Europe - MRI

NCT02791282 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1080

Last updated 2016-06-06

No results posted yet for this study

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)

Conditions

  • Pulmonary Hypertension

Interventions

OTHER

Index 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

Sponsors & Collaborators

  • University of Sheffield

    collaborator OTHER

  • University of Giessen

    collaborator OTHER

  • Ludwig-Maximilians - University of Munich

    collaborator OTHER

  • Heidelberg University

    collaborator OTHER

  • Hannover Medical School

    lead OTHER

Principal Investigators

  • Jens Vogel-Claussen, MD · Hannover Medical School

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2020-03-31
Completion
2020-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02791282 on ClinicalTrials.gov