BridgeMD
Multicentric study evaluating the usefulness of early PSMA PET scan in metastatic renal cancer requiring standard immunotherapy treatment.
EU CTIS ID: 2024-517098-26-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Non-ccRCC
- Previous anticancer systemic treatment for metastatic ccRCC
- 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)
- 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.
- 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.
See the full eligibility criteria
- 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
- Non-ccRCC
- Previous anticancer systemic treatment for metastatic ccRCC
- 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)
- 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.
- 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
- 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.
- Patients who received prior radiotherapy within 2 weeks of the first 68Ga-gozetotide dose. Radiation-related toxicities must have resolved.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.