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Study Comparing Dosimetry-Based PRRT and Standard Dose PRRT with Lutetium (177Lu) Edotreotide for Patients with Neuroendocrine Tumors

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 type of cancer called Neuroendocrine Tumor (NEN). The treatment being tested is called 177Lu-DOTATOC, which is given as an injection. The purpose of the study is to find out if it is better for patients with NEN to receive a personalized dose of this treatment, known as dosimetry-based PRRT, compared to a standard dose. PRRT stands for Peptide Receptor Radionuclide Therapy, a type of treatment that uses radioactive substances to target and kill cancer cells.

Participants in the study will be randomly assigned to receive either the dosimetry-based PRRT or the standard dose PRRT. Throughout the study, patients will undergo various tests and scans to monitor their health and the effects of the treatment. The study aims to compare the outcomes of the two different dosing methods, including how long patients live without their disease getting worse, the amount of radiation the tumor receives, and any side effects experienced, particularly those affecting the kidneys and bone marrow.

The study will also look at how the treatment affects the overall well-being of the patients, including any subjective side effects they might experience. The goal is to determine if tailoring the dose of 177Lu-DOTATOC based on individual needs can improve treatment outcomes and reduce side effects for patients with Neuroendocrine Tumor.

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, eligibility is confirmed based on specific criteria such as age, confirmed diagnosis of neuroendocrine tumor (NEN), and previous treatment history.

    A written informed consent is required before any procedures begin.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: dosimetry-based PRRT or standard dose PRRT.

    This process ensures that each participant has an equal chance of receiving either treatment.

  3. Step 3

    Treatment administration

    The treatment involves the administration of 177Lu-DOTATOC through injection.

    The frequency and dosage depend on the group assignment: dosimetry-based or standard dose.

  4. Step 4

    Monitoring and follow-up

    Regular visits are scheduled for SPECT/CT scans, laboratory tests, and other study procedures.

    These visits help monitor the treatment's effects and any potential side effects.

  5. Step 5

    Evaluation of outcomes

    The primary outcome is the difference in progression-free survival between the two groups.

    Secondary outcomes include differences in tumor dose, kidney toxicity, bone marrow function, and subjective side effects.

  6. Step 6

    Completion of the study

    The study is estimated to conclude by December 24, 2027.

    Final assessments will be conducted to evaluate the long-term effects and benefits of the treatment.

Who can join the trial?

12 criteria

  • Male or female patients must be older than 18 years.
  • The patient must have a **Neuroendocrine Tumor (NEN)** confirmed by a tissue sample test, which is called histology.
  • The patient's condition must have worsened despite standard treatments like somatostatin analogues, targeted therapy (such as Everolimus or sunitinib), or chemotherapy (such as STZ/5-FU or temozolomide/capecitabine). Alternatively, the patient may have experienced intolerable side effects from these treatments or have symptoms that are difficult to manage.
  • The patient must have a **WHO/ECOG Performance Status** of 0-2, which is a scale that measures how well a patient can perform daily activities.
  • The patient must have a life expectancy of more than 6 months.
  • The patient must have a higher uptake than the liver in the primary tumor or metastases on a **Ga-DOTATOC PET/CT** scan. If the scan is older than 3 months at the time of inclusion, a new scan should be done.
  • The patient must have adequate organ function, which includes:
    • **Adequate kidney function**: A glomerular filtration rate greater than 30 ml/min, measured by a test called Tc-DTPA clearance.
    • **Adequate bone marrow function**:
      • White blood cell count (WBC) of at least 2.0 x 109/L.
      • Platelet count of at least 100 x 109/L.
      • Hemoglobin (Hb) level of at least 6 mmol/l (or 9.67 g/dL).
      • The patient must be willing and able to attend scheduled visits for **SPECT/CT scans**, follow treatment plans, and undergo laboratory tests and other study procedures.
      • The patient must provide written informed consent before any screening procedures are conducted.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with a Neuroendocrine Tumor. A neuroendocrine tumor is a type of growth that can occur in different parts of the body and affects cells that release hormones into the blood.
  • Patients who are not within the specified age range for the study. The study is open to certain age groups only.
  • Patients who belong to 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

Lu-177-DOTATOC is a type of targeted radiation therapy used in the treatment of neuroendocrine tumors (NETs). It involves a radioactive substance, Lutetium-177, which is attached to a molecule called DOTATOC. This combination targets and binds to specific receptors on the tumor cells, allowing the radiation to directly affect the cancer cells while minimizing damage to surrounding healthy tissue. The trial is comparing two approaches: one where the dose is adjusted based on individual patient needs (dosimetry-based PRRT) and another where a standard dose is given to all patients.

What is already known about the treatment

Lu-177-DOTATOC – This medication is administered through an intravenous injection and is currently being studied in clinical trials for its effectiveness in treating neuroendocrine tumors. It is a form of peptide receptor radionuclide therapy (PRRT) that targets specific receptors on tumor cells, delivering radiation directly to the cancerous cells. The main therapeutic indication for Lu-177-DOTATOC is the treatment of neuroendocrine tumors, which are a type of cancer that arises from hormone-producing cells. At the molecular level, Lu-177-DOTATOC binds to somatostatin receptors on tumor cells, allowing the radioactive component to damage and kill the cancer cells. It is classified pharmacologically as a radiopharmaceutical used in targeted cancer therapy.

Investigated diseases

Neuroendocrine Tumor – Neuroendocrine tumors are a group of growths that originate from neuroendocrine cells, which have traits similar to both nerve cells and hormone-producing cells. These tumors can develop in various parts of the body, including the gastrointestinal tract, pancreas, and lungs. They often grow slowly and may not cause symptoms until they become large or spread to other parts of the body. Symptoms, when they occur, can vary widely depending on the tumor's location and whether it produces excess hormones. Some neuroendocrine tumors can be functional, meaning they release hormones into the bloodstream, leading to specific symptoms. Non-functional tumors do not produce hormones and may only cause symptoms due to their size or location.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517240-62-00Estimated enrolment100 patientsSponsorRegion Midtjylland

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