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Brief Summary

Liver failure is one of the most severe complications in patients undergoing liver surgery for hepatic malignancies. However, it can be predicted through preoperative assessment of liver function. Technetium-99m galactosyl human serum albumin (\[99mTc\] Tc-GSA), combined with single-photon emission computed tomography fused with computed tomography (\[99mTc\] Tc-GSA SPECT/CT), is widely used in Asia due to its superiority in predicting postoperative liver failure. Unfortunately, its clinical use in Western countries remains limited due to concerns about disease transmission. In 2022, the Department of Clinical Physiology and Nuclear Medicine at Rigshospitalet optimized the in-house production of \[99mTc\] Tc-GSA under European regulations, and in April 2025, received approval from the Danish Medicines Agency for its clinical use. This study aims to evaluate, for the first time, the diagnostic accuracy of \[99mTc\] Tc-GSA SPECT/CT in quantifying liver function in European patients with hepatic tumors. Hypothesis: \[99mTc\] Tc-GSA SPECT/CT is capable of and superior to indocyanine green clearance test (ICG), Child-Pug score, Model for End-Stage Liver Disease (MELD) score, and ultrasound elastography in quantifying liver function and predicting surgical outcomes in a Danish cohort of patients with liver tumors. Perceived quality of life may be associated with postoperative complications. However, postoperative complications and survival can be more accurately predicted when quality of life is assessed in combination with preoperative liver function and clinical conditions. Objectives Primary objectives:

1.To evaluate the correlation between \[99mTc\] Tc-GSA SPECT/CT and established liver function assessments, including ICG clearance, Child-Pugh score, MELD score, and ultrasound elastography.
2.To compare the discriminative ability of \[99mTc\] Tc-GSA SPECT/CT with existing liver function tests in predicting postoperative complications.
3.To assess the correlation of \[99mTc\] Tc-GSA SPECT/CT, ICG clearance, Child-Pugh score, MELD score, and ultrasound elastography with postoperative outcomes.
4.To develop and internally validate a multivariable predictive model combining the best predictive liver function test with preoperative clinical characteristics to predict postoperative complications.

Outcome Measures

Primary Outcomes (5)

Correlation between [99mTc] Tc-GSA SPECT/CT parameters and ICG clearance
The correlation between quantitative liver uptake parameters derived from \[99mTc\] Tc-GSA SPECT/CT and indocyanine green (ICG) clearance will be assessed using Pearson's/Spearman's rank correlation coefficient. \[99mTc\] Tc-GSA SPECT/CT units: Liver function test expresed in Uptake Index (UI) and percentage of total liver volume (FLR%). Indocyanine green (ICG) clearance units: Liver function test reported as: 1.- ICG retention ratio after 15 min (ICGR15), unit: percentage (%) 2.- Rate constant (k) of ICG indicator-dilution curve (KICG), unit: min-1 3.- Plasma dis-appearance rate of ICG (PDRICG), unit: % min-1.
Once before receiving the planned treatment for a hepatic tumor.
Correlation between [99mTc] Tc-GSA SPECT/CT parameters and Child-Pugh score
The correlation between quantitative \[99mTc\] Tc-GSA SPECT/CT-derived liver function parameters and Child-Pugh score will be assessed using Pearson's/Spearman's rank correlation coefficient. \[99mTc\] Tc-GSA SPECT/CT units: Uptake Index (UI) and percentage of total liver volume (FLR%). Child-Pug score description and units: : Scoring system that estimates cirrhosis severity. It classifies patients into three categories: A - good hepatic function, B - moderately impaired hepatic function, and C - advanced hepatic dysfunction.
Once before receiving the planned treatment for a hepatic tumor.
Correlation between [99mTc] Tc-GSA SPECT/CT parameters and the Model for End-Stage Liver Disease (MELD) score
he correlation between quantitative \[99mTc\] Tc-GSA SPECT/CT-derived liver function parameters and MELD score will be assessed using Pearson's/Spearman's rank correlation coefficient. \[99mTc\] Tc-GSA SPECT/CT units: Uptake Index (UI) and percentage of total liver volume (FLR%). MELD score definition and units: The Model for End-Stage Liver Disease (MELD) is a prognostic score to measure the severity of liver failure. The MELD score is based on results from five blood tests: Bilirubin, Creatinine, Internal normalized ratio (INR), Serum sodium, and Albumin. The MELD score ranges from 6 to 40, and quantifies end-stage liver disease for transplant planning. The higher the score, the more severe the disease.
Once before receiving the planned treatment for a hepatic tumor.
Correlation between [99mTc] Tc-GSA SPECT/CT parameters and liver stiffness measured by ultrasound elastography
The correlation between quantitative \[99mTc\] Tc-GSA SPECT/CT-derived liver function parameters and liver stiffness measured by ultrasound elastography will be assessed using Pearson's/Spearman's rank correlation coefficient. 99mTc\] Tc-GSA SPECT/CT units: Uptake Index (UI) and percentage of total liver volume (FLR%) Ultrasound elastography: kilopascals (kPa)
Once before receiving the planned treatment for a hepatic tumor.
Discriminative ability of [99mTc] Tc-GSA SPECT/CT compared with standard liver function tests to predict major postoperative complications
The discriminative ability of \[99mTc\]Tc-GSA SPECT/CT to predict major postoperative complications (Clavien-Dindo grade ≥ III) will be compared with standard liver function tests, including ICG clearance, Child-Pugh score, MELD score, and ultrasound elastography (units and definitions have been previously described). The Clavien-Dindo classification ranks the severity of surgical complications and consists of seven grades (I, II, IIIa, IIIb, IVa, IVb, and V). Complications of grade ≥ III will be considered major. Discriminative performance will be assessed using the area under the receiver operating characteristic curve (AUC) for each test. AUCs will be compared using DeLong's test.
Once after the completion of 90-day follow-up.

Secondary Outcomes (5)

Association of [99mTc] Tc-GSA, ICG, Child-Pugh, MELD, and ultrasound elastography with 90-day mortality
Once during the final analysis after completion of 90-day follow-up.
Association of [99mTc] Tc-GSA, ICG, Child-Pugh, MELD, and ultrasound elastography with post-hepatectomy liver failure
Once during the final analysis after completion of 90-day follow-up.
Association of [99mTc] Tc-GSA, ICG, Child-Pugh, MELD, and ultrasound elastography with length of stay.
Once during the final analysis after completion of 90-day follow-up.
Association of [99mTc] Tc-GSA, ICG, Child-Pugh, MELD, and ultrasound elastography with readmission.
Once during the final analysis after completion of 90-day follow-up.
Model development and internal validation of a multivariable predictive model combining the most accurate liver function test with preoperative clinical factors (frailty, sarcopenia, grip strength, age, sex, etc.) to predict complications.
Once during the final analysis after completion of 90-day follow-up.

Interventions

[99mTc] Tc-GSA SPECT/CTDiagnostic test

To evaluate preoperative liver function using \[99mTc\] Tc-GSA SPECT/CT, participants will receive an intravenous injection of 185 MBq/3 mg \[99mTc\] Tc-GSA through a peripheral vein. SPECT imaging will be performed 20 minutes after tracer injection.

All participants

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 100 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adults over 18 years who have the capacity to act, with a confirmed or suspected diagnosis of one or more hepatic tumors and a planned local treatment proposed by a multidisciplinary team of specialists, specifically those:
Patients undergoing major liver resection (FLR \< 40%).

Study Design

Study Type

interventional

Phase

phase 4

Allocation

Masking

NONE

Purpose

DIAGNOSTIC

Intervention Model

SINGLE GROUP

Model Details: The aim of this study is to evaluate the diagnostic accuracy of \[99mTc\] Tc-GSA SPECT/CT in quantifying liver function in European patients with hepatic tumors. For accomplish this objective, in 2022, the Department of Clinical Physiology and Nuclear Medicine at Rigshospitalet optimized the in-house production of \[99mTc\] Tc-GSA under European regulations, and in April 2025, received approval from the Danish Medicines Agency for its clinical use. The compassionate permit allows the use of \[99mTc\] Tc-GSA for preoperative evaluation of regional liver function in the part of the liver that is preserved after liver resection due to malignant liver disease (primary liver cancer, primary biliary cancer and colorectal liver metastases). This study will explore the benefits of using \[99mTc\] Tc-GSA in combination with SPECT/CT in patients with a confirmed or suspected diagnosis of hepatic tumor (benign ot malignant) and a planned local treatment (resection and/or ablation).

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Associate professor

Prediction of Complications in Hepatic Tumors

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (5)

Study Arms (1)

All participants

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Prediction of Complications in Hepatic Tumors

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (5)

Study Arms (1)

All participants

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations