BridgeMD
ISEE-RCC study
EU CTIS ID: 2024-514181-39-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
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
- ≥ 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.
You likely can't join if
- 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.
See the full eligibility criteria
- ≥ 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.
- 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
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.