ZIRCONIUM (89ZR) GIRENTUXIMAB

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.

Table of Contents

Trial overview

ZIRCONIUM (89ZR) GIRENTUXIMAB is being studied in two authorised interventional trials.[1][2] Both trials focus on imaging, meaning they are designed to see how well scans can find tumors in specific patient groups.[1][2]

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.[1] The other trial includes people with Von-Hippel Lindau (VHL) disease, a rare inherited condition linked to tumor growth.[2]

The first study is listed for metastatic renal cell carcinoma, meaning kidney cancer that has spread to other parts of the body.[1] The second study explores the role of Carbonic Anhydrase IX, also called CAIX, as a diagnostic and theranostic target in VHL disease.[2]

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.[1] Its main outcome is tumor detectability, which means how well each scan can find tumors.[1]

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

Trial phases and status

One study is Phase 3 and has an enrollment of 20 participants.[1] The other is Phase 2 and has an enrollment of 38 participants.[2]

Both studies are currently listed as Authorised.[1][2] They are both interventional studies, meaning researchers actively apply the imaging procedure and then measure the results.[1][2]

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.[1] 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.[1]

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.[2] 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.[2]

Trial ID Phase Condition studied Status Enrollment
2024-514181-39-00 Phase 3 Metastatic renal cell carcinoma Authorised 20
2024-515679-36-01 Phase 2 Von-Hippel Lindau disease Authorised 38

Ongoing Clinical Trials on ZIRCONIUM (89ZR) GIRENTUXIMAB

  • Study Comparing Gallium (68Ga) Gozetotide and Zirconium (89Zr) Girentuximab PET Scans for Detecting Tumors in Patients with Metastatic Renal Cell Carcinoma

    Recruiting

    3 1 1 1
    Investigated diseases:
    The Netherlands
  • Study of Zirconium-89 Girentuximab as a Diagnostic Tool for Patients with Von-Hippel Lindau Disease

    Not yet recruiting

    2 1 1
    Investigated diseases:
    Italy

Glossary

  • Metastatic renal cell carcinoma: Kidney cancer that has spread to other parts of the body.
  • Clear cell renal cell carcinoma (ccRCC): A common type of kidney cancer. In these trials, people may have suspected primary, recurrent, or metastatic disease.
  • Von-Hippel Lindau (VHL) disease: A rare inherited condition that can lead to tumor growth in different parts of the body.
  • PET-CT: An imaging test that combines PET and CT scans to help find tumors and show where they are in the body.
  • PET: A scan that shows how tissues and tumors behave in the body by using a small amount of tracer.
  • CT: A scan that gives detailed pictures of the inside of the body.
  • Tumor detectability: How well a scan can find a tumor.
  • Detection rate: The number or percentage of tumors that a scan is able to identify.
  • Efficacy: How well a test or treatment works for its intended purpose.
  • CAIX: Carbonic Anhydrase IX, a target being explored in one study for tumor imaging.
  • Interventional study: A clinical trial where researchers give a test, scan, or treatment and measure the results.

References

  1. https://clinicaltrials.gov/study/2024-514181-39-00
  2. https://clinicaltrials.gov/study/2024-515679-36-01