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Study on the Effectiveness of Lutetium (177Lu) Edotreotide for Patients with Neuroendocrine Tumors and Other SSTR-Positive Tumors

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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 the effects of a treatment called 177Lu-DOTATOC on certain types of tumors. The tumors being studied include Neuroendocrine Tumors and other tumors that are positive for a specific receptor known as SSTR. This includes conditions like Pheochromocytomas and Paragangliomas, as well as Bronchopulmonary Neuroendocrine Tumors. The treatment involves using a solution that is given through an infusion into the veins.

The purpose of the study is to evaluate how effective the 177Lu-DOTATOC treatment is for patients with these types of tumors. The study will follow patients over a period of time to see how their tumors respond to the treatment. Some patients will receive the actual treatment, while others may receive a placebo. The study will also monitor the safety of the treatment by checking for any side effects that occur during and after the treatment period.

Participants in the study will undergo regular assessments to track the progress of their disease and any changes in their quality of life. These assessments will include standard questionnaires and medical imaging tests like MRI or CT scans. The study aims to provide valuable information on the potential benefits and risks of using 177Lu-DOTATOC for treating these specific types of tumors.

The research process

The trial runs in 5 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, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

    Eligibility criteria include being 18 years or older, not pregnant or breastfeeding, and having a confirmed diagnosis of a neuroendocrine tumor or other SSTR-positive tumors.

  2. Step 2

    Treatment preparation

    Before starting treatment, a diagnostic PET/CT scan is performed to assess the tumor's uptake of the treatment agent.

    Patients must demonstrate significant uptake in the tumor to proceed with the treatment phase.

  3. Step 3

    Treatment administration

    The treatment involves the administration of lutetium (177lu) edotreotide through an intravenous infusion.

    The treatment is given in cycles, with the frequency and duration determined by the study protocol and the patient's response.

  4. Step 4

    Monitoring and evaluation

    Throughout the treatment, regular monitoring is conducted to evaluate the response to the therapy and to check for any side effects.

    The primary goal is to assess the disease control rate, which includes complete response, partial response, or stable disease.

  5. Step 5

    Follow-up

    After completing the treatment cycles, follow-up assessments are conducted to monitor long-term outcomes and any late side effects.

    Quality of life is evaluated using standardized questionnaires at various points during and after the treatment.

Who can join the trial?

11 criteria

  • Must be at least 18 years old.
  • If you are a female participant, you must not be pregnant or breastfeeding. You must use highly effective birth control methods starting from the screening visit and continuing until 6 months after the last treatment. If you are a male participant, you and your female partner must use two acceptable methods of birth control, including a condom, starting at screening and continuing throughout the study and for 6 months after the final treatment.
  • You must be willing and able to give informed consent to participate in the study.
  • You must have a confirmed diagnosis of a **neuroendocrine tumor** or another type of tumor that is **sst2-positive**. This means the tumor has specific receptors that can be targeted by the treatment. If a biopsy is not possible, a **CT** or **MRI** scan must strongly suggest the presence of the tumor.
  • You must have a measurable disease according to specific criteria, or if not measurable, it must be evaluable.
  • Any stage of the disease is allowed, but the tumor must show significant uptake in imaging tests, according to a specific scale.
  • You must have progressive disease within the last 12 months that does not respond to standard treatments. Clinical progression is allowed.
  • You can participate with or without ongoing therapy with **somatostatin analogs**, but the dose must remain the same as when the disease progression was demonstrated.
  • You must have a life expectancy of more than 6 months.
  • Your **ECOG performance status** must be 2 or less. This is a scale that measures your ability to perform daily activities.
  • You must have adequate blood, liver, and kidney function. This includes specific levels of **hemoglobin**, **neutrophils**, **platelets**, **bilirubin**, **ALT**, **AST**, **creatinine**, and **eGFR** or **creatinine clearance**.

Who cannot join the trial?

5 criteria

  • Patients who do not have **SSTR-positive tumors**. These are tumors that have a specific type of receptor on their surface.
  • Patients who are not affected by **neuroendocrine tumors**. These are a type of tumor that starts in the cells that release hormones into the blood in response to a signal from the nervous system.
  • Patients who do not have **pheochromocytomas** or **paragangliomas**. These are rare types of tumors that usually start in the adrenal glands or near certain blood vessels and nerves.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means they might need special protection or care.
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Investigated drugs

177Lu-DOTATOC is a type of targeted therapy used in this clinical trial. It involves a radioactive substance that is designed to attach to specific receptors on certain tumor cells, known as SSTR positive tumors. Once attached, the radioactive component can help to destroy the cancer cells while minimizing damage to surrounding healthy tissue. This therapy is being studied to determine how effective it is in treating patients with these types of tumors.

What is already known about the treatment

177Lu-DOTATOC – This medication is administered through intravenous infusion and is currently being studied in clinical trials for its effectiveness in treating certain types of tumors. It is primarily used for neuroendocrine tumors and other tumors that are positive for somatostatin receptors (SSTR), including pheochromocytomas and paragangliomas. The mechanism of action involves binding to somatostatin receptors on tumor cells, allowing the radioactive component, Lutetium-177, to deliver targeted radiation therapy directly to the cancer cells. It is classified as a radiopharmaceutical used in peptide receptor radionuclide therapy (PRRT).

Investigated diseases

  • Neuroendocrine Tumor

    Neuroendocrine tumors are a group of growths that originate from cells of the neuroendocrine system, which have traits of 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 are quite large or have spread to other parts of the body.

  • Other SSTR-positive Tumors

    These are tumors that express somatostatin receptors (SSTR), which are proteins found on the surface of certain cells. SSTR-positive tumors can occur in various tissues and are often associated with neuroendocrine origins. The presence of these receptors can influence the growth and behavior of the tumor.

  • Pheochromocytomas and Paragangliomas

    Pheochromocytomas are rare tumors that develop in the adrenal glands, while paragangliomas are similar tumors that occur outside the adrenal glands. Both types of tumors arise from chromaffin cells, which produce adrenaline and other hormones. They can cause episodes of high blood pressure, headaches, and sweating due to excess hormone production.

  • Bronchopulmonary and Other NETs

    These are neuroendocrine tumors that specifically occur in the lungs (bronchopulmonary) and other locations. They can vary in their growth rate and potential to spread, with some being slow-growing and others more aggressive. Symptoms may include coughing, wheezing, and difficulty breathing if the tumor affects the airways.

  • NETs Retreated with PRRT

    This refers to neuroendocrine tumors that have been treated with peptide receptor radionuclide therapy (PRRT) and are undergoing retreatment. PRRT is a targeted therapy that delivers radiation directly to the tumor cells. Retreatment may be considered if the tumor recurs or progresses after initial therapy.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519183-40-00Protocol codeIRST100.60Estimated enrolment178 patientsSponsorIstituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).