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Study on the Use of Gallium Citrate Ga-68 for Diagnosing Chronic Infections in Artificial Hip and Knee Joints

Verified siteInvestigationalNo 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 condition known as prosthetic joint infection, which can occur in people who have artificial hip or knee joints. The trial is investigating the use of a special imaging technique called positron emission tomography/computed tomography (PET/CT) with a substance called 68 Gallium citrate. This substance is injected into the body and helps to create detailed images that may assist in diagnosing infections in artificial joints.

The purpose of the study is to determine how accurate the 68 Gallium citrate PET/CT scan is in diagnosing chronic infections in artificial hip or knee joints. Participants in the study will undergo this imaging procedure to see if it can reliably identify infections. The study will also compare the results of the 68 Gallium citrate PET/CT scan with another imaging method called marked polynuclear scintigraphy to evaluate which method is more effective.

Throughout the study, researchers will assess the accuracy of the 68 Gallium citrate PET/CT scan by looking at its ability to correctly identify infections. They will also examine how consistent the results are when interpreted by different observers. The study aims to provide valuable information that could improve the diagnosis of infections in people with artificial joints, potentially leading to better treatment outcomes.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must meet specific criteria, including being over 18 years old, having a suspected infection of an artificial hip or knee joint, and having a positive bone scintigraphy result.

    The patient must be affiliated with a health insurance system and have signed an informed consent form before any examination required by the research.

  2. Step 2

    Initial assessment

    The patient undergoes routine diagnostic procedures, which include both bone scintigraphy and polynuclear scintigraphy, to confirm the suspicion of a prosthetic joint infection.

  3. Step 3

    Administration of <b>68 gallium citrate</b>

    The patient receives an injection of 68 gallium citrate, a solution administered intravenously. This is part of the diagnostic process to assess the presence of a chronic infection in the artificial hip or knee joint.

  4. Step 4

    Positron emission tomography (PET) and computed tomography (CT) scan

    Following the injection, the patient undergoes a PET/CT scan. This imaging technique helps in estimating the diagnostic accuracy of the 68 gallium citrate in detecting chronic infections in the joint prosthesis.

  5. Step 5

    Evaluation of results

    The results from the PET/CT scan are evaluated to determine the diagnostic accuracy, including sensitivity, specificity, and predictive values, for detecting chronic infections in the artificial hip or knee.

  6. Step 6

    Comparison and analysis

    The diagnostic accuracy of the 68 gallium citrate PET/CT is compared with the results from the marked polynuclear scintigraphy. This step includes assessing the reproducibility of the PET/CT interpretation by different observers and analyzing any discrepancies between the two diagnostic methods.

Who can join the trial?

7 criteria

  • Patients must be **over 18 years old**.
  • Patients should be visiting a specialized center for joint prosthesis infection for the **first time** due to a suspected infection of an artificial hip or knee.
  • There should be a **suspicion of artificial joint infection** that started at least one month before the evaluation.
  • Patients must undergo routine diagnosis that includes **screening by both bone scintigraphy and polynuclear scintigraphy**. Scintigraphy is a type of imaging test that helps doctors see how your bones are working.
  • Patients must have a **positive bone scintigraphy** result, meaning the test showed something unusual in the bones.
  • Patients need to be **affiliated with a health insurance system**.
  • Patients must have **signed an informed consent form** after understanding the study details and before any study-related examinations are done.

Who cannot join the trial?

3 criteria

  • Patients who do not have a **prosthetic joint infection**. This means the study is only for those with an infection in a joint that has an artificial replacement.
  • Patients who are not within the specified age range. The study is for adults, so children and very elderly individuals may not be eligible.
  • Patients who are part of a vulnerable population. This means people who might need special protection or care, like those with certain disabilities or conditions, may not be included.
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Investigated drugs

68Ga citrate PET/CT is a diagnostic imaging technique used in the trial to help identify chronic infections in artificial hip and knee joints. This method involves using a special radioactive substance, 68Gallium citrate, which is injected into the body. The PET/CT scan then detects the radiation emitted by the substance, allowing doctors to see detailed images of the joints and identify any signs of infection.

What is already known about the treatment

68Gallium Citrate – This medication is administered through an intravenous injection and is used in imaging procedures. It is currently being studied in clinical trials for its effectiveness in diagnosing chronic infections in artificial hip and knee joints. The main therapeutic indication is to assist in the detection of prosthetic joint infections. At the molecular level, 68Gallium citrate works by binding to areas of infection, allowing them to be visualized using positron emission tomography (PET) scans. It is classified as a radiopharmaceutical agent, which is a type of drug used in nuclear medicine for diagnostic purposes.

Investigated diseases

Prosthetic Joint Infection – This condition occurs when bacteria or other microorganisms infect the area around a joint prosthesis, such as a hip or knee replacement. It can develop shortly after surgery or years later, often causing pain, swelling, and limited movement in the affected joint. The infection may lead to the loosening of the prosthetic joint, making it difficult to use. Symptoms can include fever, warmth, and redness around the joint. The progression of the infection can vary, with some cases remaining localized while others may spread to surrounding tissues. Early detection and management are crucial to prevent further complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515781-13-00Protocol codeCHUBX 2019/24Estimated enrolment35 patientsSponsorCentre Hospitalier Universitaire De Bordeaux

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