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NCT Number: NCT07358975

Prediction of Complications in Hepatic Tumors

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.

Secondary objectives: 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.

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Key information

Conditions

Hepatic Tumors Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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%).
  • Patients undergoing minor resections or open/laparoscopic ablations with a risk of impaired liver function, defined by at least one of the following:
  • Histological diagnosis of liver cirrhosis or fibrosis (Meta-analysis of Histological Data in Viral Hepatitis scoring system [METAVIR] score 1 to 4).
  • Radiological signs of cirrhosis.
  • Preoperative chemotherapy.
  • Known liver disease associated with cirrhosis: metabolic dysfunction-associated steatohepatitis, chronic infection with hepatitis B or C, primary sclerosing cholangitis, primary biliary cholangitis, and autoimmune hepatitis.

Exclusion criteria

  • History of hypersensitivity to Technetium-99m or albumin
  • Diagnosis of pulmonary hypertension,
  • Pregnant or breastfeeding individuals. For fertile women, non-pregnancy must be confirmed by a negative pregnancy test. No contraception methods are required after the study due to the short radioactive half-life of the IMP.
  • Patients under 18 years old or unable to make autonomous care decisions.

Treatment and study plan

[99mTc] Tc-GSA SPECT/CT

Diagnostic 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.

Primary outcomes

  1. Correlation between [99mTc] Tc-GSA SPECT/CT parameters and ICG clearance

    Time frame: Once before receiving the planned treatment for a hepatic tumor.

    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.

  2. Correlation between [99mTc] Tc-GSA SPECT/CT parameters and Child-Pugh score

    Time frame: Once before receiving the planned treatment for a hepatic tumor.

    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.

  3. Correlation between [99mTc] Tc-GSA SPECT/CT parameters and the Model for End-Stage Liver Disease (MELD) score

    Time frame: Once before receiving the planned treatment for a hepatic tumor.

    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.

  4. Correlation between [99mTc] Tc-GSA SPECT/CT parameters and liver stiffness measured by ultrasound elastography

    Time frame: Once before receiving the planned treatment for a hepatic tumor.

    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)

  5. Discriminative ability of [99mTc] Tc-GSA SPECT/CT compared with standard liver function tests to predict major postoperative complications

    Time frame: Once after the completion of 90-day follow-up.

    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.

Secondary outcomes

  1. Association of [99mTc] Tc-GSA, ICG, Child-Pugh, MELD, and ultrasound elastography with 90-day mortality

    Time frame: Once during the final analysis after completion of 90-day follow-up.

    A regression model will be run between the variables. Parameters derived from [99mTc] Tc-GSA, ICG, Child-Pugh, MELD, and ultrasound elastography will be treated as independent variables, while 90-day mortality will be treated as binary and dependent variable.

    Units for [99mTc] Tc-GSA, ICG, Child-Pugh, MELD, and ultrasound elastography has been described before.

    90-day mortality categories: yes, no.

  2. Association of [99mTc] Tc-GSA, ICG, Child-Pugh, MELD, and ultrasound elastography with post-hepatectomy liver failure

    Time frame: Once during the final analysis after completion of 90-day follow-up.

    A regression model will be run between the variables. Parameters derived from [99mTc] Tc-GSA, ICG, Child-Pugh, MELD, and ultrasound elastography will be treated as independent variables, while post-hepatectomy liver failure will be treated as binary and dependent variable.

    Units for [99mTc] Tc-GSA, ICG, Child-Pugh, MELD, and ultrasound elastography has been described before.

    Post-hepatectomy liver failure categories: yes, no

  3. Association of [99mTc] Tc-GSA, ICG, Child-Pugh, MELD, and ultrasound elastography with length of stay.

    Time frame: Once during the final analysis after completion of 90-day follow-up.

    A regression model will be run between the variables. Parameters derived from [99mTc] Tc-GSA, ICG, Child-Pugh, MELD, and ultrasound elastography will be treated as independent variables, while length of stay. will be treated as dependent variable.

    Units for [99mTc] Tc-GSA, ICG, Child-Pugh, MELD, and ultrasound elastography has been described before.

    Units for length of stay: days

  4. Association of [99mTc] Tc-GSA, ICG, Child-Pugh, MELD, and ultrasound elastography with readmission.

    Time frame: Once during the final analysis after completion of 90-day follow-up.

    A regression model will be run between the variables. Parameters derived from [99mTc] Tc-GSA, ICG, Child-Pugh, MELD, and ultrasound elastography will be treated as independent variables, while readmision will be treated as binary and dependent variable.

    Units for [99mTc] Tc-GSA, ICG, Child-Pugh, MELD, and ultrasound elastography has been described before.

    Readmision: yes, no

  5. 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.

    Time frame: Once during the final analysis after completion of 90-day follow-up.

    The model performance will be assessed using penalized regression with discrimination, calibration, and bootstrap validation.

Study contacts

Contact information is provided by the study sponsor or research team.

Hans-Christian Pommergaard

CONTACT

[email protected]

+45 23 24 18 21

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Danish Cancer Society

Registry information

Official study title

Prediction of Complications in Patients Undergoing Surgical Treatment of Hepatic Tumors

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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