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Study on [68Ga]Ga-PentixaFor and [18F]FDG PET/CT Imaging for Staging Marginal Zone Lymphoma in Patients with Confirmed Diagnosis

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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 cancer called Marginal Zone Lymphoma (MZL), which is a form of lymphoma, a cancer that affects the lymphatic system. The study aims to compare two different imaging methods used to detect and stage this disease. The first method uses a special imaging agent called [68Ga]Ga-PentixaFor, and the second method uses another agent known as [18F]FDG. Both of these agents are used in a type of scan called PET/CT, which combines positron emission tomography (PET) and computed tomography (CT) to create detailed images of the body.

The purpose of the study is to determine if the [68Ga]Ga-PentixaFor imaging method is better at detecting cancerous lesions compared to the [18F]FDG method. Participants in the study will undergo both types of scans, and the results will be compared to see which method provides more accurate information about the presence and extent of the lymphoma. This comparison will help doctors understand which imaging technique is more effective for staging MZL and potentially other similar types of lymphomas.

Throughout the study, participants will receive the imaging agents through an intravenous injection, which means the substance is injected directly into a vein. The study will also assess the safety and tolerability of these imaging agents to ensure they are safe for use in patients. By participating in this trial, researchers hope to improve the way MZL is diagnosed and staged, ultimately leading to better treatment planning and management for patients with this condition.

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

    Initial assessment

    Upon joining the study, the patient undergoes an initial assessment to confirm eligibility. This includes reviewing the patient's medical history and ensuring a diagnosis of marginal zone lymphoma (MZL) is present.

    The patient must not have received any treatment for MZL prior to the trial.

  2. Step 2

    Consent and preparation

    The patient signs an informed consent form, acknowledging understanding of the trial's procedures and objectives.

    Women capable of child-bearing must provide a negative pregnancy test and agree to use effective contraception for one month after the last dose of imaging agents.

  3. Step 3

    First imaging session

    The patient receives an intravenous injection of [68Ga]Ga-PentixaFor, a solution used for positron emission tomography (PET) imaging.

    The imaging session aims to assess the presence and extent of lymphoma using this agent.

  4. Step 4

    Second imaging session

    The patient undergoes a second imaging session using [18F]FDG, another PET imaging agent.

    This session is conducted to compare the diagnostic performance of the two imaging agents.

  5. Step 5

    Follow-up and analysis

    The results from both imaging sessions are analyzed to determine the sensitivity and specificity of each agent in detecting lymphoma.

    The impact on staging and potential treatment plans is assessed based on the imaging results.

  6. Step 6

    Safety and tolerability evaluation

    Throughout the trial, the patient's safety and the tolerability of the imaging agents are monitored.

    Any side effects or adverse reactions are documented and addressed.

Who can join the trial?

9 criteria

  • The patient must sign an informed consent form, which is a document that explains the study and confirms their willingness to participate.
  • The patient can be of any gender and must be at least 18 years old.
  • The patient must have a confirmed diagnosis of Marginal Zone Lymphoma (MZL), which is a type of cancer, based on a biopsy, which is a procedure where a small sample of tissue is taken for examination.
  • The patient should not have received any treatment for their condition before joining the study.
  • Women who can become pregnant must have a negative pregnancy test and agree to use highly effective birth control for 1 month after the last dose of the study drugs.
  • Male patients with partners who can become pregnant must agree to use effective birth control for 1 month after the last dose of the study drugs.
  • The patient must have acceptable organ function, which means their organs are working well enough to participate in the study.
  • The patient should have a life expectancy of at least 12 weeks, as estimated by the doctor conducting the study.
  • The patient must not have had any treatments aimed at curing or relieving their condition between any diagnostic tests and the study scans.

Who cannot join the trial?

4 criteria

  • Patients who are not diagnosed with Marginal Zone Lymphoma cannot participate. This is a type of cancer that affects certain white blood cells.
  • Patients who are outside the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for specific types of patients.
  • Patients who are considered part of a vulnerable population cannot participate. This refers to groups of people who might be at higher risk or need special protection in research.
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Investigated drugs

  • [68Ga]Ga-PentixaFor ([68Ga]Ga-PTF)

    is a special imaging agent used in PET scans. It helps doctors see certain types of cancer cells in the body, specifically those related to marginal zone lymphoma. This agent is designed to attach to cancer cells that have a specific marker called CXCR4, making it easier to detect and assess the spread of the disease.

  • [18F]FDG

    is another imaging agent used in PET/CT scans. It is commonly used to detect cancer by highlighting areas of high glucose metabolism, which is typical in many types of cancer cells. This agent helps in identifying and staging various cancers, including lymphomas, by showing where the cancer cells are located in the body.

What is already known about the treatment

[68Ga]Ga-PentixaFor – This medication is administered as an injection and used in positron emission tomography (PET) imaging. It is currently being studied in a phase 3 clinical trial for its effectiveness in diagnosing marginal zone lymphoma, a type of cancer. The main therapeutic indication is to improve the accuracy of cancer staging by targeting CXCR4-positive malignant lymphomas. At the molecular level, it works by binding to the CXCR4 receptor, which is often overexpressed in certain cancer cells, allowing for better imaging of tumors. It is classified as a diagnostic radiopharmaceutical agent.

Investigated diseases

Marginal Zone Lymphoma – Marginal Zone Lymphoma is a type of non-Hodgkin lymphoma that originates in the marginal zone of lymphoid tissue, which is part of the immune system. It typically progresses slowly and can affect various parts of the body, including the spleen, lymph nodes, and mucosal tissues. The disease often presents with symptoms such as swollen lymph nodes, fatigue, and sometimes abdominal discomfort. As it advances, it may spread to other organs, but it generally remains indolent for a long period. The progression can vary significantly among individuals, with some experiencing stable disease for years.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500918-25-00Protocol codePTF301Estimated enrolment148 patientsSponsorPentixapharm AG

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