Changes in functional capacity of the contralateral liver lobe after unilobar 90Y-radioembolization – correlation with volumetric measurements (the RadioEmbolization, Volumetry, and Liver funcTion - REVoluTion study)

Recruiting

• Conditions: Patient has got metastasis of the liver; C20; C19; C18; C17; C78.7; Malignant neoplasm of rectum; Malignant neoplasm of rectosigmoid junction; Malignant neoplasm of colon; Malignant neoplasm of small intestine

• Registration Number: DRKS00007162
• Lead Sponsor: niversitätsklinikum Magdeburg

Brief Summary

Results: Twenty-three patients were evaluated (11 metastatic colorectal cancer, 4 cholangiocellular carcinoma, 3 metastatic breast cancer, 1 each of metastatic neuroendocrine tumor, hepatocellular carcinoma, renal cell carcinoma, oesophageal cancer, pancreatic ductal adenocarcinoma). In the untreated contralateral left liver lobe, mean (SD) metabolic function significantly increased from 1.34 (0.76) %/min/m2 at baseline to 1.56 (0.75) %/min/m2 6 weeks after RE (P=0.024). The mean (SD) functional volume (liver volume minus tumor volume) of the left liver lobe significantly increased from baseline (407.3 [170.3] mL) to follow-up (499.1 [209.8] mL; P<0.01), with an equivalent magnitude to the metabolic function increase. There were no reports of grade =3 adverse events. Conclusion: This study indicates that unilobar RE produces a significant increase in the metabolic function, and equivalent volume increase, of the contralateral lobe. RE may be a useful option to induce hypertrophy of the future liver remnant before surgical resection of primary or second

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-26
• Results First Posted: 2021-09-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients (aged 18-85 years) undergoing unilateral or sequential radioembolization Y 90 for secondary liver malignancies
- Performance status ECOG 0-2
- lnformed consent

Exclusion Criteria

- Baseline functional volume of the non-embolized lobe >30% of total functional liver volume
- Liver cirrhosis
- Pre-existing portal vein thrombosis
- Hepatocellular carcinoma, cholangiocellular carcinoma
- Patients with a history of local therapy or surgery on the left liver tobe or patients who are planned for a local therapy or sugrery on the left lobe in follow-up period
- Tumor load in the left liver lobe of >10%
- Contraindications for hepatobiliary MRI or Gd-EOB-DTPA or hepatobiliary scintigraphy

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the changes in liver function of the nonembolized lobe before and after unilobar radioembolization. LIMONTEST and liver function scintigraphy are performed before and after therapy.

Secondary Outcome Measures

Name	Time	Method
To determine the relation between volumetric and functional response in the contralateral lobe before and after unilobar radioembolization.