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ZIRCONIUM (89ZR) GIRENTUXIMAB Clinical Trials in Renal Cell Carcinoma and VHL Disease

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In short

ZIRCONIUM (89ZR) GIRENTUXIMAB is being studied in clinical trials to see how well it helps find tumors on PET scans. The trials focus on people with metastatic renal cell carcinoma and Von-Hippel Lindau disease, and they measure tumor detection and imaging performance.

Key points

  • Clinical trials of ZIRCONIUM (89ZR) GIRENTUXIMAB are studying tumor imaging in two main groups: people with metastatic renal cell carcinoma and people with Von-Hippel Lindau disease. One trial is Phase 3 and compares tumor detection on PET-CT with other imaging methods, while the other is Phase 2 and looks at CAIX-PET for finding tumors in VHL disease. The studies include patients with suspected primary, recurrent, or metastatic clear cell renal cell carcinoma as well as patients with VHL disease. The main focus is how well tumors can be detected, not treatment effects. Both trials are interventional and are designed to measure imaging performance in defined patient groups.

Trial overview

ZIRCONIUM (89ZR) GIRENTUXIMAB is being studied in two authorised interventional trials. Both trials focus on imaging, meaning they are designed to see how well scans can find tumors in specific patient groups.

Who is being studied

One trial includes patients with suspected primary, recurrent, or metastatic clear cell renal cell carcinoma (ccRCC), which is a type of kidney cancer. The other trial includes people with Von-Hippel Lindau (VHL) disease, a rare inherited condition linked to tumor growth.

The first study is listed for metastatic renal cell carcinoma, meaning kidney cancer that has spread to other parts of the body. The second study explores the role of Carbonic Anhydrase IX, also called CAIX, as a diagnostic and theranostic target in VHL disease.

What the trials measure

The Phase 3 study compares the tumor detection rate of 68Ga-gozetotide PET-CT with ZIRCONIUM (89ZR) GIRENTUXIMAB PET-CT, both added to conventional contrast enhanced CT. Its main outcome is tumor detectability, which means how well each scan can find tumors.

The Phase 2 study measures the efficacy of CAIX-PET for detecting tumors in patients with VHL disease. In simple terms, it asks whether the scan works well for finding tumors in this group.

Trial phases and status

One study is Phase 3 and has an enrollment of 20 participants. The other is Phase 2 and has an enrollment of 38 participants.

Both studies are currently listed as Authorised. They are both interventional studies, meaning researchers actively apply the imaging procedure and then measure the results.

Trial details

The study titled ISEE-RCC study compares ZIRCONIUM (89ZR) GIRENTUXIMAB PET-CT with 68Ga-gozetotide PET-CT and conventional contrast enhanced CT in patients with suspected metastatic ccRCC. Its brief summary says the study is exploratory and looks at tumor detection visually and semi-quantitatively, which means the scans are reviewed by eye and also by numbers.

The study titled CAT-VHL - Exploring the role of Carbonic Anhydrase IX as diagnostic and Theranostic target in Von-Hippel Lindau disease evaluates CAIX-PET for detecting tumors in VHL disease. Its brief summary says it is exploring Carbonic Anhydrase IX as a diagnostic and theranostic target, meaning a target that may help both with finding disease and guiding future care.

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