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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of kidney cancer known as clear cell renal cell carcinoma (ccRCC), which can spread to other parts of the body, a condition referred to as metastatic renal cell carcinoma. The study aims to compare two different imaging methods to see how well they can detect tumors in patients suspected of having this type of cancer. The two imaging methods being compared are 68Ga-gozetotide (PSMA) PET and 89Zr-DFO-girentuximab PET. These are special scans that help doctors see where the cancer might be in the body.

The purpose of the study is to explore and compare how effectively these two imaging methods can find tumors. Patients will receive both types of scans, and the results will be compared to see which method is better at detecting the cancer. The study will also look at how the cancer appears in these scans compared to a standard imaging method called computed tomography (CT), which uses X-rays to create detailed pictures of the inside of the body.

During the study, patients will undergo these imaging tests, and the results will be analyzed to determine the best way to detect tumors in this type of kidney cancer. The study will help doctors understand which imaging method provides the most accurate information about the presence and spread of the cancer, potentially leading to better diagnosis and treatment options for patients with metastatic renal cell carcinoma.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing the suspicion of metastatic clear cell renal cell carcinoma (ccRCC) based on a recent contrast-enhanced CT scan.

    Eligibility requires that the CT scan be performed no more than four weeks prior to the PET scan. A biopsy may or may not have been conducted before joining the study.

  2. Step 2

    First imaging session

    The first imaging session involves the administration of gallium (68Ga) gozetotide via intravenous injection. This is a solution for injection used to perform a PET scan.

    The purpose of this scan is to visually and semi-quantitatively assess tumor detection rates.

  3. Step 3

    Second imaging session

    The second imaging session involves the administration of zirconium (89Zr) girentuximab via intravenous injection. This is also a solution for injection used for a PET scan.

    This session aims to compare the tumor detection rates with those from the first imaging session.

  4. Step 4

    Data analysis

    The data from both PET scans, along with the conventional contrast-enhanced CT, are analyzed to evaluate tumor detectability and detection rates.

    The analysis includes a semi-quantitative assessment of the maximum standardized uptake value (SUVmax) in the primary tumor and metastases, as well as the tumor-to-background ratio.

Who can join the trial?

6 criteria

  • Must be **18 years** or older.
  • There should be a **suspicion of metastatic ccRCC** (a type of kidney cancer that has spread to other parts of the body) based on a **contrast-enhanced CT scan**. This scan should be done no more than 4 weeks before the PET scan.
  • The diagnosis of the cancer may or may not be confirmed by a **biopsy** (a small sample of tissue taken from the body to examine it more closely) before joining the study.
  • The **primary tumor** (the original cancer site) may or may not still be present in the body.
  • Both **male and female** participants are eligible.
  • Participants should not belong to a **vulnerable population** (groups that may need special protection or care).

Who cannot join the trial?

3 criteria

  • Patients who do not have **metastatic renal cell carcinoma**. This is a type of kidney cancer that has spread to other parts of the body.
  • Patients who are not within the specified age range. The study is open to certain age groups, so if you are outside this range, you cannot participate.
  • Patients who are part of a vulnerable population. This means people who might need special protection or care, such as those with certain disabilities or conditions.
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Investigated drugs

  • 68Ga-gozetotide (PSMA)

    is a type of imaging agent used in PET scans to help detect tumors. It targets a specific protein found on the surface of certain cancer cells, making it easier for doctors to see these cells during imaging tests. This helps in identifying the presence and spread of cancer in the body.

  • 89Zr-girentuximab

    is another imaging agent used in PET scans. It binds to a different protein that is often present in kidney cancer cells. By attaching to these cells, it allows doctors to visualize the cancer more clearly during imaging, aiding in the diagnosis and monitoring of the disease.

What is already known about the treatment

  • 68Ga-gozetotide

    This medication is administered through an injection and is used in PET scans to help detect tumors in patients with suspected renal cell carcinoma. It is currently being explored in clinical trials to assess its effectiveness in identifying cancerous cells. The main therapeutic indication is for imaging in cases of suspected metastatic renal cell carcinoma. At the molecular level, it targets the PSMA protein, which is often found in higher amounts on cancer cells, allowing for better visualization during scans. It is classified as a radiopharmaceutical used in diagnostic imaging.

  • 89Zr-DFO-girentuximab

    This medication is also administered via injection and is used in PET scans to detect tumors in patients with suspected renal cell carcinoma. It is under investigation in clinical trials to compare its tumor detection capabilities with other imaging agents. The primary therapeutic use is for imaging in cases of suspected metastatic renal cell carcinoma. Its mechanism involves binding to a specific protein on cancer cells, enabling enhanced imaging during scans. It falls under the category of radiopharmaceuticals used for diagnostic purposes.

Investigated diseases

Metastatic Renal Cell Carcinoma – This is a type of kidney cancer that has spread beyond the kidney to other parts of the body. It originates in the renal cortex, where the cells begin to grow uncontrollably, forming a tumor. As the disease progresses, cancer cells can travel through the bloodstream or lymphatic system to distant organs, such as the lungs, bones, or liver. The spread of cancer cells to other parts of the body is known as metastasis. This condition can lead to various symptoms depending on the organs affected, such as pain, fatigue, or weight loss. The progression of the disease can vary, with some patients experiencing rapid spread while others may have a slower progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514181-39-00Protocol code115747Estimated enrolment20 patientsSponsorStichting Radboud universitair medisch centrum

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