In short
Technetium (99MTC) galactosyl serum albumin, also known as [99mTc] Tc-GSA, is an investigational protein-based diagnostic substance given by intravenous injection. It is being studied in a Phase 3 trial with 192 participants to help predict complications after surgery for hepatic tumors. The trial compares this imaging method with standard liver function tests.
Key points
- Phase 3 trial in hepatic tumors with 192 participants.
- Given as a solution for injection by intravenous administration at a dose of 200 MBq.
- Trial status is Authorised in the EU Clinical Trials Information System.
- Primary goal is to compare Tc-99m GSA SPECT/CT with standard liver function tests for predicting postoperative complications.
- It is an investigational substance with no marketing authorisation in these records.
What is Technetium (99MTC) galactosyl serum albumin?
Technetium (99MTC) galactosyl serum albumin, referred to as [99mTc] Tc-GSA, is a protein-based substance used as a diagnostic imaging agent. It is classified as an investigational substance with no marketing authorisation in the product records. The substance is prepared as a solution for injection and is given by intravenous administration. It is supplied by RHPET.
How does Technetium (99MTC) galactosyl serum albumin work?
Technetium (99MTC) galactosyl serum albumin is designed to bind to receptors on liver cells. When combined with single-photon emission computed tomography fused with computed tomography (SPECT/CT), it allows doctors to see how well the liver is functioning. The imaging shows the distribution of the substance in the liver, which reflects the activity of healthy liver tissue.
Which conditions is it used or studied for?
- Hepatic tumors – The substance is being studied to help predict complications in patients undergoing surgical treatment for tumors of the liver.
How is Technetium (99MTC) galactosyl serum albumin given?
Technetium (99MTC) galactosyl serum albumin is given as a solution for injection by intravenous administration. In the registered trial, a dose of 200 megabecquerels (MBq) is used.
What do the clinical trials show?
One Phase 3 trial is registered for this substance. The trial is authorised and plans to enroll 192 participants with hepatic tumors. The study has two main goals. First, it will measure the correlation between Tc-99m GSA SPECT/CT results and established liver function assessments, including the indocyanine green (ICG) clearance test, Child-Pugh score, Model for End-Stage Liver Disease (MELD) score, and ultrasound elastography. Second, it will compare the ability of Tc-99m GSA SPECT/CT with standard liver function tests to predict major postoperative complications, defined as Clavien–Dindo grade 3 or higher.
In a published case report, 99m-Technetium galactosyl human serum albumin scanning was used to evaluate liver function after stereotactic body radiotherapy for hepatocellular carcinoma.
What side effects are known?
The provided sources do not report specific side effects for Technetium (99MTC) galactosyl serum albumin.