Overview
Sponsor-declared trial summary
Metastatic renal cell carcinoma
This explorative study aims to investigate and compare (both visually and semi-quantitatively) the tumor detection rates of 68Ga-gozetotide (PSMA) PET and 89Zr-DFO-girentuximab PET in patients suspected of having primary, recurrent or metastatic ccRCC.
Key facts
- Sponsor
- Stichting Radboud universitair medisch centrum
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Diseases [C] - Neoplasms [C04], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
- Trial duration
- 23 Sep 2025 → ongoing
- Decision date (initial)
- 2025-02-25
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
This explorative study aims to investigate and compare (both visually and semi-quantitatively) the tumor detection rates of 68Ga-gozetotide (PSMA) PET and 89Zr-DFO-girentuximab PET in patients suspected of having primary, recurrent or metastatic ccRCC.
Conditions and MedDRA coding
Metastatic renal cell carcinoma
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-516648-24-00 | IMPD-Q-only application | Telix Innovations |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- ≥ 18 years
- Suspicion of metastatic ccRCC on conventional contrast-enhanced CT (performed max. 4 weeks prior to the PET scan). Diagnosis may or may not be proven by biopsy prior to inclusion in the study. Primary tumor may or may not be in place.
Exclusion criteria 8
- History of a CAIX-negative, PSMA negative or non-clear cell RCC.
- Administration of tyrosine kinase inhibitors within 1 month prior to inclusion.
- Renal insufficiency with GFR ≤ 45 mL/min/1.73m2
- Second active malignancy (except basal-cell carcinoma).
- Administration of a radioisotope within 10 physical half-lives prior to study enrollment.
- Possibility of pregnancy (anamnestic, if ambiguity; a pregnancy test will be conducted prior to the PET/CT) or lactation.
- Known hypersensitivity or formation of human anti-chimeric antibodies (HACA) against girentuximab or DFO.
- No verbal and written command of Dutch language
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- To evaluate the tumor detectability/detection rate (descriptive) of 68Ga-gozetotide (PSMA) PET-CT compared to 89Zr-DFO-girentuximab PET-CT (both in addition to conventional contrast enhanced CT) in patients with the suspicion of metastatic ccRCC. The denominator will consist of the conventional diagnostic contrast enhanced CT, 68Ga-gozetotide (PSMA) PET-CT and 89Zr-DFO-girentuximab PET-CT.
Secondary endpoints 2
- The semi-quantitative assessment of the SUVmax in primary tumor (if in situ) and SUVmax of metastases (lesion based analyses).
- Tumor-to-background ratio of primary tumor (if in situ) and tumor-to-background ratio of metastases.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD9614939 · Product
- Active substance
- Zirconium (89ZR) Girentuximab
- Substance synonyms
- 89Zr-TLX250, 89Zr-DFO-girentuximab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 37 MBq megabecquerel(s)
- Max total dose
- 37 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- TELIX INTERNATIONAL PTY LTD
- Paediatric formulation
- No
- Orphan designation
- No
Gallium (68Ga) PSMA-11 (gozetotide) prepared using PSMA-11 Sterile Cold Kit
PRD10121760 · Product
- Active substance
- Gallium (68GA) Gozetotide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 259 MBq megabecquerel(s)
- Max total dose
- 259 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- TELIX INNOVATIONS
- Paediatric formulation
- No
- Orphan designation
- No
SCP105625076 · ATC
- Active substance
- Gozetotide
- Substance synonyms
- AAA517, OH-Glu-CO-Lys(Ahx-CC-HBED)-OH
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 259 MBq megabecquerel(s)
- Max total dose
- 259 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09IX14 — GALLIUM (68GA) GOZETOTIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Stichting Radboud universitair medisch centrum
- Sponsor organisation
- Stichting Radboud universitair medisch centrum
- Address
- Geert Grooteplein Zuid 10
- City
- Nijmegen
- Postcode
- 6525 GA
- Country
- Netherlands
Scientific contact point
- Organisation
- Stichting Radboud universitair medisch centrum
- Contact name
- dr. Stijn Muselaers
Public contact point
- Organisation
- Stichting Radboud universitair medisch centrum
- Contact name
- dr. Stijn Muselaers
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 | 2025-09-23 | 2025-10-03 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-514181-39-00_Redacted | 3 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC Illuccix_Benelux-NL | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_USPI USA version of SmPC Gallium 68 Gozetotide | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL 2024-514181-39-00 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-23 | Netherlands | Acceptable 2025-02-20
|
2025-02-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-25 | Netherlands | Acceptable 2026-05-18
|
2026-05-18 |