K74.6
Conditions
Interventions
Group 1: Possible study participants are patients who, due to known cirrhosis of the liver, undergo CT diagnostics to clarify a nodule, e.g are compatible in terms of inclusion and exclusion criteria.
Sponsors
Universitätsklinik Tübingen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Patients with liver cirrhosis and HCC-suspect liver lesions (mainly hepatocellular carcinoma) who are before/during/after curative or palliative (systemic) therapy and patients who are about to have a liver transplant and therefore need the exclusion of HCC-suspicious lesions. • The patient's willingness to cooperate, in particular an adequate understanding of the German language. • Unrestricted ability of the patient to consent. • Information about the study nature of the investigation • Willingness to participate in the study, which is confirmed by signature • Written declaration of consent to perform a computed tomography • A GFR greater than 60 mL/min. According to the current state of knowledge, the application of iodinated contrast medium to patients with a GFR > 60 ml/min is considered harmless
Exclusion criteria
Exclusion criteria: • Patients with biguanide therapy (metformin in diabetes mellitus) • past allergic reaction to non-ionic contrast media • Pregnancy and breastfeeding women (due to the underlying disease of the patient group to be examined (tumor disease), pregnancy should be considered unlikely. However, this is also supported by questioning the patient. For safety reasons, a pregnancy test is carried out in every questionable case). • extreme obesity (body diameter > diameter of the examination opening in the CT; currently permitted body weight 150 kg) • Multiple myeloma • known claustrophobia • Manifest/latent hyperthyroidism (TSH basal 3 times normal) • Heart failure NYHA III-IV stage. • Missing written declaration of consent. • Age: < 18 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of the present study is to enable an already established VP-CT of the liver (4D spiral acquisition computer tomography) on the new PCD-CT in patients with known liver cirrhosis and thus to generate an immediate improvement in diagnostic accuracy. A protocol with a lower radiation dose is used compared to the preliminary examinations on the EID-CT. In addition, the role of the VP-CT in PCD-CT alone and/or in combination with a downstream MRI should be defined. To back up this approach, all available histological data should be used for diagnosis. Furthermore, an MRI examination in the follow-up period serves as confirmation if no histological confirmation is available. | — |
Secondary
| Measure | Time frame |
|---|---|
| A therapy-accompanying prospective data acquisition without additional use of X-rays should be carried out with the aim of a later retrospective data evaluation. The duration of the study is set at 24 months. The group of patients to be examined is to be examined as part of routine diagnostics using the test method (4D spiral acquisition computed tomography) and the routine clinical and laboratory parameter examinations as a reference method and compared with a downstream MRI. There are no additional blood draws. Imaging diagnostics are clinically-indicated and conform to current guidelines in the field. The evaluation of the collected data will flow directly into the therapy decision. | — |
Countries
Germany
Outcome results
None listed