Overview
Sponsor-declared trial summary
Histologically confirmed solid malignancy (e.g., head and neck, gastrointestinal, hepatobiliary, breast, genitourinary, sarcoma)
To determine the optimal dose and timing of intravenous ICG to achieve sufficient tumor-to background contrast in solid tumors and to evaluate whether ICG fluorescence imaging can accurately identify tumor margins during surgery.
Key facts
- Sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-01-13
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Erasmus MC
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
To determine the optimal dose and timing of intravenous ICG to achieve sufficient tumor-to background contrast in solid tumors and to evaluate whether ICG fluorescence imaging
can accurately identify tumor margins during surgery.
Secondary objectives 5
- To determine the sensitivity, specificity, PPV, and NPV of fluorescence imaging for tumor detection.
- To assess the number and pathology of additional fluorescent lesions identified intraoperatively.
- To determine if fluorescence imaging can identify lymph node metastases.
- To evaluate the safety and tolerability of ICG at tested doses.
- To assess the relationship between standard clinical imaging modalities (CT, MRI, ultrasound, nuclear imaging) and ICG fluorescence with respect to tumor characteristics and perfusion
Conditions and MedDRA coding
Histologically confirmed solid malignancy (e.g., head and neck, gastrointestinal, hepatobiliary, breast, genitourinary, sarcoma)
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Age ≥18 years
- Histologically confirmed solid malignancy (e.g., head and neck, gastrointestinal, hepatobiliary, breast, genitourinary, sarcoma)
- Candidate for surgical resection with curative intent
- Ability to provide written informed consent
- Adequate organ function to undergo surgery and ICG administration
Exclusion criteria 5
- Known allergy to Indocyanine Green (ICG), iodine, or shellfish
- Pregnant or breastfeeding
- Significant renal impairment (eGFR <50 mL/min/1.73 m²)
- Hyperthyroidism or other active thyroid disease
- Any condition deemed by the investigator to place the patient at undue risk or interfere with study procedures
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Tumor-to-background ratio (TBR) ≥ 1.5 on ex vivo imaging of resected specimens.
- Proportion of patients with histologically confirmed clear surgical margins (≥1 mm) in fluorescent vs. non-fluorescent areas
Secondary endpoints 5
- Concordance between fluorescence signal and histopathology at wound bed and specimen
- Number of additional fluorescent lesions biopsied and confirmed as tumor, as well as the number of false-positive and false-negative lesions
- Mean fluorescence intensity (MFI) in metastatic vs. non-metastatic lymph nodes
- Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
- Concordance of ICG fluorescence with complementary imaging or spectroscopy signals, clinical findings, and histopathological outcomes.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
VERDYE 5 mg/ml poeder voor oplossing voor injectie
PRD10944472 · Product
- Active substance
- Indocyanine Green
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFUSION
- Max daily dose
- 5 mg/kg milligram(s)/kilogram
- Max total dose
- 5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CX01 — -
- Marketing authorisation
- BE273892
- MA holder
- DIAGNOSTIC GREEN LIMITED
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Sponsor organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Address
- Dr. Molewaterplein 40
- City
- Rotterdam
- Postcode
- 3015 GD
- Country
- Netherlands
Scientific contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Dr. D.E. Hilling
Public contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Dr. D.E. Hilling
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 40 | 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 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol 2025-523898-42-00 clean | 2 |
| Protocol (for publication) | D1 Protocol 2025-523898-42-00 tracked changes | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_clean | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_tracked_changes | 1.1 |
| Subject information and informed consent form (for publication) | L1__NL-NL_SIS and ICF_description_SURF_clean | 2 |
| Subject information and informed consent form (for publication) | L1__NL-NL_SIS and ICF_description_SURF_tracked_changes | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Indocyanine Green | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2025-523898-42-00 | 1.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-16 | Netherlands | Acceptable 2026-01-13
|
2026-01-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-04-03 | Netherlands | Acceptable 2026-04-28
|
2026-04-28 |