Patients with low or moderate clinical probability for pulmonary embolism and positive or negative CTA for pulmonary embolism after CT and sonographic examination for deep venous thrombosis.
Conditions
Interventions
Trade Name: Vasovist®
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Gadofosveset
Concentration unit: mmol/kg millimole(s)/kilogram
Concentration type: up to
Concentration number: 0,
Sponsors
Administration management, Ludwig-Maximilians-University of Munich
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with low or moderate clinical probability for pulmonary embolism (Wells score, see appendix 1) and positive or negative CTA for pulmonary embolism. Patients who are willing to undergo MRA with Vasovist® -after getting a detailed information about the treatment by an (co)investigator- and will give their signed informed consent form. The distribution of gender is irrelevant. The patient group reflects the clinic's average. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Less than 18 years of age. Women who are pregnant, lactating or who are of childbearing potential and have not had a negative urine pregnancy test the same days as administration of Vasovist®. The manufacturer’s instructions for performing the urinary pregnancy test are to be followed. People with proven central pulmonary embolism (main left or right pulmonary artery) Known underlying pulmonary disease: e.g. lung cancer, chronic obstructive pulmonary disease Having an underlying disease or concomitant medication (or are scheduled for any therapy) which may interfere with efficacy or safety evaluations as planned in this study Having any physical or mental status that interferes with the informed consent procedure incl. self-signed consent. Having a history of alcohol or drug abuse or dependency. Having received any investigational drug within 30 days prior to entering this study or who are planned to receive any other investigational drug during the 24 (+ 4) hours safety follow-up period. Not being able to remain lying down for at least 45 – 60 min (e.g. patients with unstable angina, dyspnea at rest, severe pain at rest, severe back pain). Presenting with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents. Presenting sickle cell disease or other hemolytic anemia. Being clinically unstable Being scheduled for, or likely to require, any surgical intervention within 24 hours before or within the follow-up period. Having any contraindication to MRI examination or specifically for MRA (e.g. pacemaker, recent wound clips, and severe claustrophobia). High clinical probability for PE Patient who have received Gadolinum within 24 hours prior to Vasovist® injection. Patients with impaired renal function as indicated by CreatininClearance below 30ml/min (MDRD/Cockroft-Gault) (laboratory diagnostic data required) Patients with impaired liver function (laboratory diagnostic data required)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ;Main Objective: To assess the feasibility and accuracy of comprehensive whole-body 3T MRA of patients with low or moderate clinical probability for pulmonary embolism using an intravascular MR contrast agent (Vasovist®) for detection of pulmonary embolism and underlying deep venous thrombosis in a single examination.;Primary end point(s): Feasibility: number technically successful MRI exams. A successful exam is defined as a completed imaging protocol (First-pass MRA (perfusion MRI), steady-state MRA, MR venography) with diagnostic image quality (as determined by the blinded reading) Accuracy: Accuracy (sensitivity, specificity, accuracy, PPV, NPV) of MRI for the detection of pulmonary embolism and venous thrombosis compared to the gold standard (CTA and venous ultrasound) Total imaging time of MRI (First-pass MRA (perfusion MRI), steady-state MRA, MR venography). Subjective image quality of MRI (1=non-diagnostic, 2=poor, 3=moderate, 4=good, 5=excellent). | — |
Countries
Germany
Outcome results
None listed