Hepatic TumorsPhase 4NCT07358975
Prediction of Complications in Hepatic Tumors
A Phase 4 study testing [99mTc] Tc-GSA SPECT/CT in people with Hepatic Tumors, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hepatic Tumors
- What is being tested?
- [99mTc] Tc-GSA SPECT/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2026to Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Rigshospitalet
Copenhagen, 2100
Hans-Christian Pommergaard, +45 23 24 18 21, hans-christian.pommergaard@regionh.dk
hans-christian.pommergaard@regionh.dk
About this study
Official title: Prediction of Complications in Patients Undergoing Surgical Treatment of 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.
Read more
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:
- 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.
- To compare the discriminative ability of [99mTc] Tc-GSA SPECT/CT with existing liver function tests in predicting postoperative complications. Secondary objectives:
- To assess the correlation of [99mTc] Tc-GSA SPECT/CT, ICG clearance, Child-Pugh score, MELD score, and ultrasound elastography with postoperative outcomes.
- To develop and internally validate a multivariable predictive model combining the best predictive liver function test with preoperative clinical characteristics to predict postoperative complications.
- Conditions
- Hepatic Tumors
- Being tested
- [99mTc] Tc-GSA SPECT/CT
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[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.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | Not described Receives: Diagnostic Test: [99mTc] Tc-GSA SPECT/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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
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.
Measured: 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
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
Measured: 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.
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
Measured: 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.
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
Measured: 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.
The model performance will be assessed using penalized regression with discrimination, calibration, and bootstrap validation.
Measured: Once during the final analysis after completion of 90-day follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study startMar 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic TumorsStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society
- Responsible party
- Principal investigator, Hans-Christian Pommergaard, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358975
- Sponsor's protocol ID
- GSA-HEPSURU-RH
- Status last verified
- Nov 2025
- First submitted
- 5 Dec 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Complications in Patients Undergoing Surgical Treatment of Hepatic Tumors
- ClinicalTrials.gov ID
- NCT07358975
- Acronym / sponsor ID
- GSA-HEPSURU-RH
- Conditions
- Hepatic Tumors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- Mar 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- To compare the discriminative ability of [99mTc] Tc-GSA SPECT/CT with existing liver function tests in predicting postoperative complications. Secondary objectives:
- To assess the correlation of [99mTc] Tc-GSA SPECT/CT, ICG clearance, Child-Pugh score, MELD score, and ultrasound elastography with postoperative outcomes.
- To develop and internally validate a multivariable predictive model combining the best predictive liver function test with preoperative clinical characteristics to predict postoperative complications.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Diagnostic Test: [99mTc] Tc-GSA SPECT/CT |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [99mTc] Tc-GSA SPECT/CTTo 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. | Diagnostic test | All participants |
Primary outcome
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.
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.
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.
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)
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.
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing [99mTc] Tc-GSA SPECT/CT in people with Hepatic Tumors, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hans-Christian Pommergaard (+45 23 24 18 21, hans-christian.pommergaard@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between [99mTc] Tc-GSA SPECT/CT parameters and ICG clearance (time frame: Once before receiving the planned treatment for a hepatic tumor.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.