E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Computed tomography of suspected pulmonary embolism |
Datortomografi av misstänkt lungemboli |
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E.1.1.1 | Medical condition in easily understood language |
Computed tomography of suspected pulmonary embolism |
Datortomografi av misstänkt lungemboli |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To develop and evaluate a computed tomography protocol for ruling out pulmonary embolism using a minimal amount of contrast medium. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the image noise and vessel opacification in the reduced contrast medium dose protocol compared to standard protocol |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age >= 40 years - Referred for computed tomography concerning thorax/chest-abdomen, or similar
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E.4 | Principal exclusion criteria |
- Referral including question of aortic dissection or aortic aneurysm. - Previous hypersensitivity to iodinized contrast agent, CT-examination planned with prophylaxis against hypersensitivity reaction or clinical request to minimize contrast agent dose. - Previous examination with iodinized contrast agent within the last 48 hours. - CT-protocol selection for clinical series not suitable for combination with study protocol. - Contrast agent dose for clinical series > 100 ml, or not suitable for combination with study protocol. - Patient weight >85 kg. - Estimated Glomerular Filtration Rate <60 ml/min. - Serum or plasma creatinine test older than 24 hours (acute referral) / older than 3 months (non-acute referral/planned examinations). - Patient requiring continous medical surveillance. - Patient requiring interpreter or inable to follow breathing instructions for examination. - Pregnant, potentially pregnant or nursing women, according to the patient. - Patient unable to perform CT-examination with arms above the head or patient without periferal venous catheter in the arm. - Thyrotoxicosis or Myastenia gravis
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E.5 End points |
E.5.1 | Primary end point(s) |
Subjective image quality for diagnosticating or ruling out pulmonary embolism.
Diagnosed pulmonary embolism. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The endpoints are evaluated in a separate session after LVLS, when all computed tomography acquisitions are performed. |
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E.5.2 | Secondary end point(s) |
Image noise.
Vessel opacification. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The endpoints are evaluated in a separate session after LVLS, when all computed tomography acquisitions are performed. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Samma IMP i standarddosering |
The same IMP at standard dose |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |