Clinical trial • Not applicable • Oncology|Gastroenterology|Other

Technetium (99mTc) galactosyl serum albumin for Hepatic tumor|Hepatic tumor(s)

Not applicable trial of Technetium (99mTc) galactosyl serum albumin for Hepatic tumor|Hepatic tumor(s).

Overview

Trial Therapeutic Area
Oncology|Gastroenterology|Other
Trial Disease
Hepatic tumor|Hepatic tumor(s)
Trial Stage
Not applicable
Drug Modality
Radiopharmaceutical

Key dates

Initial CTIS Submission Date
11-12-2025
First CTIS Authorization Date
17-03-2026

Trial design

Standard liver function tests (indocyanine green (ICG) clearance test, Child-Pugh score, MELD score, ultrasound elastography) — diagnostic/test comparators; no drug comparator specified.-controlled Not applicable trial across 1 site in Denmark.

Comparator
Standard liver function tests (indocyanine green (ICG) clearance test, Child-Pugh score, MELD score, ultrasound elastography) — diagnostic/test comparators; no drug comparator specified.
Target Sample Size
192

Eligibility

Recruits 192 Vulnerable populations not selected (isVulnerablePopulationSelected: false). Participants unable to make autonomous care decisions are explicitly excluded ('Participants unable to make autonomous care decisions'). No additional details on consent/assent handling for vulnerable groups are provided in the record..

Pregnancy Exclusion
Pregnant or breastfeeding individuals
Vulnerable Population
Vulnerable populations not selected (isVulnerablePopulationSelected: false). Participants unable to make autonomous care decisions are explicitly excluded ('Participants unable to make autonomous care decisions'). No additional details on consent/assent handling for vulnerable groups are provided in the record.

Inclusion criteria

  • {"criterion_text":"- Age ≥18 years\n- Confirmed or suspected diagnosis of hepatic tumor\n- Planned local treatment following a multidisciplinary team conference conducted at the Copenhagen University Hospital, Rigshospitalet"}

Exclusion criteria

  • {"criterion_text":"- Patients aged with a history of hypersensitivity to Technetium-99m or albumin\n- Pregnant or breastfeeding individuals\n- Participants unable to make autonomous care decisions"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Correlation between Tc-99m GSA SPECT/CT and ICG clearance, Child-Pugh score, MELD score, and ultrasound elastography.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Discriminative ability of Tc-99m GSA SPECT/CT compared with standard liver function tests to predict major postoperative complications (Clavien–Dindo ≥ 3)","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Association of Tc-99m GSA, ICG, Child-Pugh, MELD, and ultrasound elastography with 90-day mortality, post-hepatectomy liver failure, length of stay, and readmission.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 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.","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
192
Recruitment Window Months
29
Consent Approach
Informed consent is required from participants (study inclusion criterion: Age ≥18 years). Subject information and informed consent form documents are listed ('L1_SIS and ICF (for all participants)', 'Dine rettigheder som forsgsperson i forsg med medicin'), but the record does not provide the text of the consent/assent process, age-specific documents, or languages. Participants unable to make autonomous care decisions are excluded.

Geography

Total Number Of Sites
1
Total Number Of Participants
192

Denmark

Earliest CTIS Part Ii Submission Date
11-03-2026
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
6
Number Of Sites
1
Number Of Participants
192

Sites

Site Name
Rigshospitalet
Department Name
Department of Digestive Diseases, Transplantation, and General Surgery
Principal Investigator Name
Hans-Christian Pommergaard
Principal Investigator Email
Hans-Christian.Pommergaard@regionh.dk
Contact Person Name
Hans-Christian Pommergaard

Sponsor

Primary sponsor

Full Name
Rigshospitalet
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"GCP unit at University of Copenhagen","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Educational Institution"}

Investigational products

Investigational Product Name
[99mTc] Tc-GSA
Active Substance
Technetium (99mTc) galactosyl serum albumin
Modality
Radiopharmaceutical
Routes Of Administration
Intravenous administration
Route
Intravenous administration
Authorisation Status
Authorised
Maximum Dose
200 MBq

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