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Evaluating kidney cancer aggressiveness using Rubidium Chloride PET scan imaging in patients with renal cell carcinoma

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What is this trial about?

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

This clinical trial focuses on studying kidney carcinoma, a type of cancer that develops in the kidneys. The study uses Rubidium Chloride, a radioactive substance that helps create detailed images of the kidney tumors using a special scanning technique called Positron Emission Tomography (PET). This imaging method allows doctors to examine how aggressive the kidney cancer is without requiring additional invasive procedures.

The purpose of this research is to determine whether the amount of Rubidium-82 absorbed by the tumor can accurately indicate how aggressive the cancer is. During the study, participants will receive a single injection of Rubidium Chloride through a vein (given intravenously) before undergoing the PET scan. The maximum amount of radioactive substance used will be 2300 MBq (megabecquerels, a measure of radioactivity).

The scanning procedure will take place before patients undergo their planned surgery for tumor removal. The images obtained from the PET scan will be compared with the actual tumor tissue examined after surgery to verify if this new imaging method can accurately predict the aggressiveness of kidney tumors. This information could help doctors make better treatment decisions for future patients with kidney cancer.

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 <b>PET scan</b> preparation

    You will receive an intravenous injection of rubidium chloride, a substance that helps create detailed images of your kidneys

    The injection will be administered through a vein in your arm

    This substance allows the scanning device to create detailed pictures of your kidney tumor

  2. Step 2

    <b>PET imaging</b> procedure

    You will lie still on the scanning table while the PET machine takes images of your kidneys

    The scan will measure how the rubidium moves through your kidney tissue

    The imaging process will focus on your kidney tumor, which should be between 2 and 7 centimeters in size

  3. Step 3

    Surgical procedure

    After the imaging is complete, you will undergo the planned surgical removal of the kidney tumor

    The surgery will be performed according to standard medical procedures

    The removed tumor tissue will be examined in the laboratory

  4. Step 4

    Follow-up assessment

    Your kidney function will be monitored through blood tests

    A follow-up examination will occur three months after the surgery

    The medical team will measure your kidney function by checking creatinine clearance (a blood test that shows how well your kidneys are working)

Who can join the trial?

9 criteria

  • You must be at least 18 years old
  • You must be willing to sign a written consent form to participate in the study
  • You must have French Social Security coverage
  • You must have either a suspected or confirmed kidney tumor that requires surgery
  • Your kidney tumor must be between 2 and 7 centimeters in size and show specific features on imaging tests (appears as a highly vascular lesion that enhances with contrast similar to kidney tissue on CT scan)
  • You must be willing and able to:
    • Attend all scheduled medical visits
    • Follow treatment plans
    • Complete required laboratory tests
    • Comply with other study procedures

Who cannot join the trial?

11 criteria

  • Age below 18 years or above 64 years
  • Patients who are pregnant or breastfeeding
  • Previous history of other types of cancer
  • Patients who cannot undergo PET scanning (a type of medical imaging that uses small amounts of radioactive material)
  • Patients with severe kidney dysfunction other than cancer
  • Patients who have received any cancer treatment in the last 30 days
  • Known allergy to medical contrast agents or radioactive tracers
  • Inability to lie still for the duration of the scanning procedure
  • Patients with metal implants or devices that could interfere with imaging
  • Patients who cannot provide informed consent
  • Participation in other clinical trials within the past 30 days
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Investigated drugs

Rubidium-82 (82-Rb) is a radioactive tracer used in Positron Emission Tomography (PET) scanning. This imaging agent helps doctors see how the kidneys function and evaluate kidney tumors. When injected into the body, it allows the PET scanner to create detailed images that can show differences between aggressive and less aggressive forms of kidney cancer. The substance is safe and quickly eliminated from the body after the scan is complete.

What is already known about the treatment

Rubidium-82 - A radioactive imaging agent administered intravenously for Positron Emission Tomography (PET) scanning, specifically used in this trial for kidney cancer assessment. This short-lived radioisotope helps create detailed images of kidney tissue, allowing doctors to evaluate the aggressiveness of renal cell carcinoma by measuring how intensely the tissue absorbs the tracer. As a diagnostic radiopharmaceutical, it belongs to the class of molecular imaging agents and works by emitting positrons that are detected by PET scanners to create detailed 3D images of the kidneys.

Investigated diseases

Kidney carcinoma - A type of cancer that begins in the cells of the kidneys, specifically in the small tubes that filter blood and remove waste products. The disease typically starts as a small growth in one kidney that can gradually increase in size over time. As the condition progresses, abnormal cells multiply and form a tumor within the kidney tissue. Kidney carcinoma can develop in people of any age, though it's more common in older adults. The disease may affect one or, less commonly, both kidneys simultaneously. This cancer can vary in its growth rate and characteristics, with different subtypes showing distinct patterns of development.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514085-39-00Protocol codeAPHP231442Estimated enrolment60 patientsSponsorAssistance Publique Hopitaux De Paris

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