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Study of 64Cu-DOTATATE and 18F-FDG PET/CT imaging to predict disease progression in patients with neuroendocrine neoplasms

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What is this trial about?

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

This study focuses on patients with Neuroendocrine Neoplasms (tumors that develop from cells of the hormone system). The research uses two different imaging substances: 64Cu-DOTATATE and 18F-FDG, which are special solutions given through an injection into a vein. These substances help create detailed images of tumors using a special type of scanning called PET/CT (a combination of two imaging techniques that produces detailed pictures of the body's internal structures).

The purpose of this study is to develop new ways to predict how long patients with neuroendocrine neoplasms might remain stable without their disease getting worse. This will be done by analyzing measurements from combined scans using both imaging substances. During the study, participants will receive both types of imaging solutions and undergo PET/CT scanning.

Both imaging substances are given as single injections into a vein. 64Cu-DOTATATE attaches to specific receptors found on neuroendocrine tumors, while 18F-FDG helps show how active the tumor cells are. The combination of these two different types of scans provides doctors with more complete information about the tumor's characteristics and behavior.

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 imaging scan - first day

    You will receive an intravenous injection of 64Cu-DOTATATE, which is a special imaging solution that helps detect neuroendocrine tumors.

    A PET/CT scan (a detailed body imaging test) will be performed to create detailed pictures of your body's tissues.

  2. Step 2

    Second imaging scan - same day

    You will receive an intravenous injection of 18F-FDG (fluorodeoxyglucose), another imaging solution.

    A second PET/CT scan will be performed to obtain additional images of your body's tissues.

  3. Step 3

    Follow-up period

    Your health status will be monitored to track how long you remain without disease progression.

    The monitoring period will continue until December 31, 2026.

    The medical team will record information about your overall survival and disease progression.

  4. Step 4

    Data analysis

    The images from both scans will be analyzed to measure tumor characteristics.

    The results will be used to create predictive models about disease progression.

    The scan results will also help determine if you might be suitable for additional treatments in the future.

Who can join the trial?

5 criteria

  • Must be 18 years of age or older
  • Must have a confirmed diagnosis of gastro-pancreatic neuroendocrine neoplasm (a type of tumor that develops in the digestive system or pancreas) through tissue examination, or have tumor spread (metastases) suggesting this type of cancer
  • Must be able to read and understand patient information and provide informed consent
  • Must have a WHO Performance status of 0-2 (this measures a patient's ability to care for themselves, where 0 means fully active and 2 means able to do light activities but unable to work)
  • Both men and women can participate in this study

Who cannot join the trial?

11 criteria

  • Age below 18 years or above 65 years
  • Inability to undergo PET/CT scanning (a type of medical imaging that combines two scanning techniques)
  • Known allergies or hypersensitivity to the imaging agents (18FDG and 64Cu-DOTATATE)
  • Pregnancy or breastfeeding
  • Inability to provide informed consent
  • Previous participation in another clinical trial within the past 30 days
  • Severe claustrophobia (fear of confined spaces) that would prevent scanning
  • Metal implants or devices that could interfere with imaging
  • Inability to lie still for the duration of the scanning procedure (approximately 30-45 minutes)
  • Serious medical conditions that could interfere with study participation
  • History of other active cancers in the past 5 years (except for adequately treated non-melanoma skin cancer)
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Investigated drugs

64Cu-DOTATATE is a radioactive tracer used in PET/CT imaging. It specifically binds to receptors commonly found on neuroendocrine tumors, helping doctors to visualize these tumors and their spread throughout the body. This imaging agent helps to create detailed pictures of where neuroendocrine tumors are located. 18F-FDG (fluorodeoxyglucose) is also a radioactive tracer used in PET/CT imaging. It works by showing areas in the body that use a lot of glucose (sugar), which is common in fast-growing cancer cells. This imaging agent helps doctors see how active the tumor cells are and can help determine how aggressive the cancer might be. Both tracers are used together in this study to provide complementary information about neuroendocrine tumors, helping doctors better understand the disease and predict how patients might respond to treatment.

What is already known about the treatment

  • 64Cu-DOTATATE

    A radioactive diagnostic imaging agent administered intravenously for PET/CT scanning, specifically designed to detect neuroendocrine tumors. This radiopharmaceutical works by binding to somatostatin receptors that are typically overexpressed in neuroendocrine tumor cells, allowing for precise imaging and localization of these tumors. It belongs to the class of peptide receptor radionuclide imaging agents and is currently used in clinical trials to evaluate its effectiveness in predicting disease progression and treatment outcomes.

  • 18F-FDG

    A radioactive form of glucose (fluorodeoxyglucose) administered intravenously for PET/CT imaging that helps detect areas of high metabolic activity, which is characteristic of many cancer cells. This tracer works by accumulating in cells that consume large amounts of glucose, making it particularly useful in identifying aggressive tumors and monitoring their response to treatment. It belongs to the radiopharmaceutical class and is widely used in clinical practice as a standard imaging agent for various types of cancer, including neuroendocrine neoplasms.

Investigated diseases

Neuroendocrine neoplasms - A group of tumors that develop from specialized cells called neuroendocrine cells, which have traits of both nerve cells and hormone-producing cells. These tumors can form in various parts of the body, most commonly in the digestive tract, pancreas, or lungs. Neuroendocrine neoplasms grow at different rates, with some developing slowly while others progress more rapidly. These tumors may produce excess hormones that can cause distinct symptoms depending on the type of hormone being overproduced. The condition varies greatly from person to person in terms of location, behavior, and symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516156-18-00Protocol codeAK_NEN_DOTA-FDG_21Estimated enrolment200 patientsSponsorRigshospitalet

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