2024-517098-26-00RecruitingPhase 2
Multicentric study evaluating the usefulness of early PSMA PET scan in metastatic renal cancer requiring standard immunotherapy treatment.
Multicentric trial evaluating the correlation between early PSMA-PET change and response to systemic treatment for first-line metastatic clear cell Renal Carcinoma Cell.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 13 Feb 2026
Brief summary (registry, in English)
To evaluate the value of early change in the PSMA expression (highlighted by 68Ga) in the PET/CT in the prediction of anticancer treatment efficacy response in metastatic renal cancer patients, as defined by the Disease Control Rate (DCR) assessed at 6-month.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 12 Dec 2024
- Start date
- 15 Jul 2026
- Lead sponsor
- Cliniques Universitaires Saint-Luc
- Diseases
- Kidney cancer
- EU CT number
- 2024-517098-26-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 75
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with metastatic clear cell kidney cancer who are about to start standard immunotherapy-based treatment. It studies whether an early PSMA PET scan can predict how well the treatment works.
- Age
- Adults, over 18 years (minimum age 18 years).
- Sex
- Men and women can join.
- Disease stage
- Metastatic clear cell renal cell carcinoma (kidney cancer), proven by tissue examination. A sarcomatoid component is allowed.
- Earlier treatment
- Cannot have had earlier anticancer systemic treatment for metastatic clear cell kidney cancer. Must be able to receive an ICI + ICI or ICI + TKI combination.
- Biomarker or test result
- Must have PSMA positive lesions on a PSMA-PET/CT scan.
Main reasons for not taking part
- Kidney cancer that is not clear cell type
- Another cancer now or in the last 3 years (some exceptions)
- Active uncontrolled or symptomatic brain (CNS) metastases
- Other anticancer therapy at the same time
- Pregnancy or breastfeeding
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous anticancer systemic treatment for metastatic ccRCC
- Patient with active uncontrolled or symptomatic central nervous system (CNS metastases). Patients treated previously with radiotherapy and/or surgery resulting in controlled/asymptomatic CNS disease are allowed. Controlled/asymptomatic CNS disease is defined as radiological stable without evidence of progression for at least 4 weeks by repeat imaging performed prior to first dose of 68Ga-gozetotide and clinically stable without requirement of steroid treatment for at least 2 weeks prior to first dose of study treatment.
- Patients treated with other concomitant anticancer therapy.
- Patients who received prior radiotherapy within 2 weeks of the first 68Ga-gozetotide dose. Radiation-related toxicities must have resolved.
Other illness
- Concurrent malignancy or previous malignancy in the last 3 years prior to start the study (with the exception of a history of adequately treated cervical carcinoma in situ or non-melanoma skin cancer)
- Patients with a hypersensitivity to the active substance of 68Ga-PSMA-11 or to one of its excipients as described in the SmPC of Locametz.
Other
- Non-ccRCC
- Pregnancy must be excluded and a pregnancy test must be done within 72 hours before each administration of 68Ga-gozetotide for women of childbearing potential.
- Breastfeeding women are excluded from the trial
Who the study is looking for
- Adult patients (>18 years), male or female
- Histologically proven clear cell Renal Carcinoma Cell (ccRCC). Sarcomatoid component is allowed
- Patient eligible for ICI + ICI combination or ICI + TKI combination
- Patient with expected survival of at least 6 months
- Patients with PSMA positive lesions on PSMA-PET/CT (which is expected to be found in 90% of patients)
- Patients able to consent
- Metastatic ccRCC
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Grand Hopital de Charleroi | Charleroi | Belgium | Recruiting |
| Chu Helora | La Louvière | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc | Sint-Lambrechts-Woluwe | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.