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Could a simple scan prevent deadly liver failure after surgery?

NCT ID NCT07358975

Diagnosis Sponsor: Rigshospitalet, Denmark Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a special imaging scan (Tc-GSA SPECT/CT) to see if it can predict liver failure after surgery for liver tumors. About 192 adults in Denmark will receive the scan before their operation. The goal is to compare this new method with standard tests and find the best way to identify high-risk patients, potentially improving surgical safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Technetium-99m galactosyl human serum albumin (Tc-GSA) injection
What this could lead to
If successful, this scan could help doctors better predict which patients are at risk of liver failure after surgery, leading to safer procedures and fewer complications.
What could go wrong
This is an early-phase study in a small group of patients in Denmark. The scan may not prove more accurate than existing tests, and results may not apply to other populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 192 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 1. Patients undergoing major liver resection (FLR \< 40%). 2. 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.

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Conditions

The condition(s) this trial relates to.

hepatobiliary neoplasm hepatocellular carcinoma liver and intrahepatic bile duct neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatic tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Rigshospitalet

    Copenhagen, 2100, Denmark

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