Overview
Sponsor-declared trial summary
Hepatic tumor
1. To evaluate the correlation between Technetium-99m galactosyl human serum albumin combined with single-photon emission computed tomography fused with computed tomography (Tc-99m GSA SPECT/CT) and established liver function assessments, including indocyanine green (ICG) clearance test, Child-Pugh score, Model for E…
Key facts
- Sponsor
- Rigshospitalet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Digestive System Diseases [C06], Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
- Decision date (initial)
- 2026-03-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Danish Cancer Society (Kraeftens Bekaempelse)
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Diagnosis
1. To evaluate the correlation between Technetium-99m galactosyl human serum albumin combined with single-photon emission computed tomography fused with computed tomography
(Tc-99m GSA SPECT/CT) and established liver function assessments, including indocyanine green (ICG) clearance test, Child-Pugh score, Model for End-Stage Liver Disease (MELD) score, and ultrasound elastography.
2. To compare the discriminative ability of Tc-99m GSA SPECT/CT with existing liver function tests in predicting postoperative complications.
Secondary objectives 2
- To assess the correlation of Tc-99m 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 and MedDRA coding
Hepatic tumor
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Age ≥18 years
- Confirmed or suspected diagnosis of hepatic tumor
- Planned local treatment following a multidisciplinary team conference conducted at the Copenhagen University Hospital, Rigshospitalet
Exclusion criteria 3
- Patients aged with a history of hypersensitivity to Technetium-99m or albumin
- Pregnant or breastfeeding individuals
- Participants unable to make autonomous care decisions
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Correlation between Tc-99m GSA SPECT/CT and ICG clearance, Child-Pugh score, MELD score, and ultrasound elastography.
- Discriminative ability of Tc-99m GSA SPECT/CT compared with standard liver function tests to predict major postoperative complications (Clavien–Dindo ≥ 3)
Secondary endpoints 2
- 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.
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD13205153 · Product
- Active substance
- Technetium (99MTC) Galactosyl Serum Albumin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 200 MBq megabecquerel(s)
- Max total dose
- 200 MBq megabecquerel(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- RHPET
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rigshospitalet
- Sponsor organisation
- Rigshospitalet
- Address
- Blegdamsvej 9
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Rigshospitalet
- Contact name
- Hans-Christian Pommergaard
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Hans-Christian Pommergaard
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| GCP unit at University of Copenhagen ORL-000005038
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 192 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-524477-17-00 | 5 |
| Protocol (for publication) | D4_ Patient facing documents_ EQ-5D-5L- quality of life questionnaire | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Subject information and informed consent form (for publication) | Dine rettigheder som forsgsperson i forsg med medicin | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF (for all participants) | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-11 | Denmark | Acceptable 2026-03-16
|
2026-03-17 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-13 | Denmark | Acceptable 2026-03-16
|
2026-05-13 |