MR- versus CT-guided biopsy of liver lesions <2 cm to optimize hit rate.- MR. CORRECT trial

Not Applicable

Recruiting

Conditions: C22.0
C78.7
Liver cell carcinoma
Secondary malignant neoplasm of liver and intrahepatic bile duct

Registration Number: DRKS00032070

Lead Sponsor: MU München

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 147

Inclusion Criteria

Clinical indication for image-guided liver biopsy. The indication for image-guided intervention in this case must be independent of the study presented.
- Maximum focal size 2 cm
- No contraindication to MRI examination or CT examination with the respective contrast agent.
- Platelets >50,000/mm3 (50 GPt/l)
- PTT-INR/PTT <1.5 times upper normal value (patients taking anticoagulants may be included if no underlying coagulation abnormality has been previously identified)
- Signed informed consent form
- Age >18 years

Exclusion Criteria

- Lack of consent and/or lack of capacity to consent to the study.
- Contraindications for an MRI examination, especially implants not suitable for MR, tattoos or piercings, limiting claustrophobia
- Contraindications for a CT examination
- Contraindications for contrast media:
o Known allergy to MR or CT contrast agents.
o Higher grade renal insufficiency (GFR <30 ml/min).
- Contraindications to image-guided interstitial intervention.
o Platelets <50,000/mm3 (50 GPt/l)
o PTT-INR/PTT >1.5 times upper normal value
o Presence of a coagulation abnormality

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recording of the clinical success rate (hit rate) of the liver lesion demonstrated either by the positive result in the histopathological examination of the punch biopsy (correlating to the known tumor entity) or by a confirmation of the negative result in the histopathological examination by the imaging result in the follow-up MRI examination after 3 months.

Secondary Outcome Measures

Name	Time	Method
- To assess the technical success rate of MR-guided biopsy compared to CT-guided biopsy.<br>- To assess the complication rate of MR-guided biopsy compared to CT-guided biopsy.<br>- Survey of the duration of the procedure in MR-guided biopsy compared to that under CT-guidance.