Recruiting

Evaluating the use of technetium (99mTc) galactosyl serum albumin to predict complications in patients undergoing surgery for liver tumors

Verified siteInvestigational

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals with a Hepatic tumor, which is a growth or mass found in the liver. The research aims to determine if a specific imaging method can better predict potential health problems following surgery to remove these tumors. During the study, a substance called technetium (99mtc) galactosyl serum albumin is administered through an intravenous administration, which means it is delivered directly into a vein. This substance is used in combination with SPECT/CT, a specialized imaging technique that combines different types of scans to create detailed pictures of the body.

The process involves comparing the results of the new imaging method with standard ways of checking how well the liver is working. These existing methods include the indocyanine green clearance test, which measures how the liver processes a specific dye, and various scoring systems like the Child-Pugh score and the MELD score used to assess liver health. Additionally, ultrasound elastography, a non-invasive way to check the stiffness of the liver, may be used. By comparing these different tools, the study seeks to find the most accurate way to identify patients who might face complications after their surgery.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Administration of the test substance
An injection of 200 MBq (a unit used to measure radioactivity) of technetium (99mtc) galactosyl serum albumin is given through an intravenous administration (directly into a vein).
This substance is used to perform a Tc-99m GSA SPECT/CT scan, which is a specialized imaging procedure that combines different types of medical scans to look at how the liver functions.
Step 2
Liver function assessments
Various tests are performed to evaluate how well the liver is working. these include the indocyanine green (ICG) clearance test, which measures how quickly the liver removes a specific dye from the blood.
Liver health is also assessed using the child-pugh score and the model for end-stage liver disease (MELD) score, which are systems used to measure the severity of liver disease.
An ultrasound elastography is performed, which is a non-invasive imaging test used to measure the stiffness of the liver.
Step 3
Monitoring of surgical outcomes
Following the surgical treatment of the hepatic tumor (a growth in the liver), the progress is monitored to identify any postoperative complications (problems that occur after surgery).
The monitoring includes tracking the length of hospital stay, any need for readmission to the hospital, and checking for post-hepatectomy liver failure (a condition where the liver cannot function properly after part of it is removed).

Who can join the trial?

4 criteria

You must be at least 18 years old.
You must have a confirmed or suspected hepatic tumor, which is an abnormal growth or mass found in the liver.
You must be scheduled to receive local treatment, which means a medical procedure aimed at treating the tumor in a specific area of the body.
Your treatment plan must have been decided during a multidisciplinary team conference, which is a meeting where different types of medical specialists work together to agree on the best care plan for you.

Who cannot join the trial?

4 criteria

People who have had an allergic reaction, also known as hypersensitivity, to Technetium-99m or albumin (a protein found in blood).
Individuals who are currently pregnant or breastfeeding.
People who are unable to make their own independent decisions regarding their medical care.
Individuals with a hepatic tumor, which is a growth or mass located in the liver.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Rigshospitalet
Copenhagen, Denmark

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Technetium-99m galactosyl serum albumin is a special liquid injected into the bloodstream that acts as a tracing agent. It is used during medical imaging to help doctors see how well the liver is functioning by showing how the liver absorbs and processes the substance.

What is already known about the treatment

Technetium (99mTc) Galactosyl Serum Albumin - This medication is an injectable solution administered directly into a vein to help visualize liver function. It is a specialized diagnostic agent used in medical imaging to assess how well the liver is working, particularly in patients with liver tumors. At a molecular level, this substance works by binding to specific receptors on the surface of liver cells, allowing doctors to see the health and activity of the liver using a special scanning camera. It is classified as a radiopharmaceutical used for diagnostic purposes.

Investigated diseases

Hepatic tumor - This is an abnormal growth of cells within the liver. These growths can arise from the liver cells themselves or from other organs that spread to the liver. As the condition progresses, the tumor cells multiply and can increase in size. This process can disrupt the normal structure and function of the liver tissue.