Overview
Sponsor-declared trial summary
penile carcinoma
The feasibility of intraoperative visualization of primary penile and tongue tumours using c-Met-based receptor-mediated fluorescence imaging.
Key facts
- Sponsor
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 17 Dec 2019 → ongoing
- Decision date (initial)
- 2024-11-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518046-25-00
- EudraCT number
- 2019-003022-24
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
The feasibility of intraoperative visualization of primary penile and tongue tumours using c-Met-based receptor-mediated fluorescence imaging.
Secondary objectives 3
- Detection and visualization of lymph node metastases in penile and tongue tumour patients
- Identification of dysplasia or carcinoma in situ in penile and tongue tumours.
- Toxicity by CTCAE-NCI V4
Conditions and MedDRA coding
penile carcinoma
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Written informed consent, prior to performing any protocol related procedures.
- Age ≥ 18 years at time of study entry.
- ≥ T1 penile or tongue squamous cell cancer
- Scheduled for surgical primary tumour resection
Exclusion criteria 4
- Involvement in the planning and/or conduct of the study.
- Pregnant woman
- Abstaining from usage of two forms of barrier contraceptive or actively planning pregnancy within 90 days.
- Severe kidney insufficiency
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The feasibility of intraoperative tumour visualization by means of c-MET targeted fluores-cence imaging will be evaluated, and the imaging result will be correlated to the level of c-MET expression determined using standard immunohistochemistry.
Secondary endpoints 2
- Detection and visualization of lymph node metastases in penile and tongue tumour patients.
- Identification of dysplasia or carcinoma in situ in penile and tongue tumours.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11641101 · Product
- Active substance
- AC-ALA-GLY-SER-CYS1-TYR-CYS2-SER-GLY-PRO-PRO-ARG-PHE-GLU-CYS2-TRP-CYS1-TYR-GLU-THR-GLU-GLY-THR-GLY-GLY-GLY-LYSUNK-NH2 Conjugated to CY5 Dye
- Substance synonyms
- EMI-137, GE-137
- Pharmaceutical form
- POWDER FOR INJECTION
- Route of administration
- INTRAVENOUS BOLUS INJECTION/IV INFUSION
- Max daily dose
- 0.13 mg/kg milligram(s)/kilogram
- Max total dose
- 0.13 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- HET NEDERLANDS KANKER INSTITUUT-ANTONI VAN LEEUWENHOEK ZIEKENHUIS STICHTING
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Sponsor organisation
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Address
- Plesmanlaan 121
- City
- Amsterdam
- Postcode
- 1066 CX
- Country
- Netherlands
Scientific contact point
- Organisation
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Contact name
- M. Baris Karakullukcu
Public contact point
- Organisation
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Contact name
- M. Baris Karakullukcu
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2019-12-17 | 2019-12-17 |
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_ INFLUENCE_protocol_2024-518046-25-00_Redacted | 1.1 |
| Recruitment arrangements (for publication) | transition EDT-CTIS_ blanco document | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF influence_penis_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF influence_tong_Redacted | 1.2 |
| Synopsis of the protocol (for publication) | D1_ Protocol samenvatting N19IFC_ 2024-518046-25-00 | 1.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-22 | Netherlands | Acceptable 2024-11-12
|
2024-11-12 |