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Evaluation of DOTATATE and GOZETOTIDE for Diagnosis and Treatment in Patients with Solid Tumors and Brain Metastases

Verified siteRegistered drugNo placebo
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What is this trial about?

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

The study focuses on patients whose solid tumors have spread to the brain, a condition known as brain metastases. It includes people with SCLC, HER2-positive Breast Cancer, and Triple Negative Breast cancer. Two investigational agents are used for imaging: an intravenous injection of NETSPOT, which contains the radioactive substance DOTATATE, and a separate injection of Locametz, which contains GOZETOTIDE. These agents help doctors see whether the cancer cells in the brain express a specific target.

The purpose of the study is to determine how often the target is present and whether a therapeutic radioactive drug can shrink the brain lesions. After receiving the diagnostic injection, participants undergo a scanning procedure called PET/CT, which combines two types of imaging to create detailed pictures of the brain. If the scan shows the target, a therapeutic radioligand may be given, and doctors will later assess the response using the RANO-BM criteria, a standard way to judge whether brain tumors have gotten smaller, stayed the same, or grown.

Participants will attend several visits over several months for the injections, imaging tests, and follow‑up assessments to monitor any changes in the brain lesions. The study follows a set schedule of visits but does not require any additional procedures beyond the described scans and injections.

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

    Diagnostic Injection and Imaging

    You will receive an intravenous injection of NETSPOT, which contains the active substance dotatate at a dose of 200 MBq (megabecquerel).

    The injection is given on the scheduled visit day and is followed by a PET/CT scan (Positron Emission Tomography combined with Computed Tomography) to look for the presence of the target in brain lesions.

  2. Step 2

    Evaluation of Diagnostic Results

    The images from the PET/CT scan are examined to determine whether the target is expressed in the intracranial lesions.

    If the target is detected, you will be offered the therapeutic part of the study.

  3. Step 3

    Therapeutic Injection

    You will receive an intravenous injection of Locametz, which contains the active substance gozetotide at a dose of 259 MBq (megabecquerel).

    This therapeutic dose is administered as a single injection on the designated treatment day.

  4. Step 4

    Follow‑Up Imaging and Response Assessment

    After the therapeutic injection, follow‑up imaging studies are performed to evaluate the effect on brain lesions.

    The response is assessed using the RANO‑BM criteria (Response Assessment in Neuro‑Oncology Brain Metastases), which classifies the result as complete response, partial response, or other outcomes.

  5. Step 5

    Study Completion

    Based on the imaging results and response assessment, the study participation concludes.

    You will receive a summary of the findings from the diagnostic and therapeutic evaluations.

Who can join the trial?

15 criteria

  • Patient must be able to understand the purpose of the study and sign a written informed consent form (ICF) before any study procedures begin.
  • Patient must be at least 18 years old when signing the consent.
  • Patient must have a tissue diagnosis (by pathology or cell analysis) showing a locally advanced, unresectable, or metastatic solid tumor.
  • Patient must have at least one brain lesion that can be measured on a special MRI scan (T1‑weighted, gadolinium‑enhanced) and is at least 10 mm in size, using the RANO‑BM criteria.
  • Patient may or may not have type II leptomeningeal disease (LMD), which means cancer cells in the lining of the brain, as defined by the European Association of Neuro‑Oncology and European Society for Molecular Oncology criteria.
  • Patient must be on a stable dose of corticosteroids (steroid medication) or not using any steroids for at least 7 days before enrollment.
  • Patient must have an ECOG performance status of 0, 1, or 2 (meaning they are fully active to able to care for themselves but unable to work).
  • Patient must be expected to live at least 6 weeks at the time of screening.
  • Patient must have adequate blood, liver, and kidney function based on tests done within the last 7 days:
    • Blood (hematology): white blood cell count > 3.0 × 10⁹/L, absolute neutrophil count ≥ 1.5 × 10⁹/L, platelet count ≥ 100 × 10⁹/L, and hemoglobin ≥ 9.0 g/dL.
    • Liver: serum albumin ≥ 2.5 g/dL; total bilirubin ≤ 1.5 times the normal upper limit (≤ 3 if the patient has liver metastases or Gilbert’s disease); alkaline phosphatase ≤ 2.5 times normal (≤ 5 if liver metastases); AST and ALT ≤ 3 times normal (≤ 5 if liver metastases); INR < 1.5.
    • Kidney: serum creatinine ≤ 1.5 times the normal upper limit or creatinine clearance ≥ 50 mL/min/1.73 m² (estimated with the Cockcroft‑Gault formula if needed).
    • Any recent side effects from previous anticancer therapy must have resolved to a mild level (grade 1 or lower) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
    • Women who could become pregnant and are sexually active with a male partner who is not sterile must have a negative pregnancy test at screening and again within 14 days before starting treatment, must use a highly effective method of contraception until a specified time after the last dose, and must not donate eggs or breastfeed during that period.
    • Men who are sexually active with a woman who could become pregnant must be surgically sterile (e.g., vasectomy) or use an acceptable method of contraception from screening until a specified time after the last dose, and must not donate or bank sperm during that period.
    • Patient must be reachable for the planned treatment visits and follow‑up appointments.

Who cannot join the trial?

15 criteria

  • You cannot be enrolled in another clinical trial (any study testing a new treatment or observation) at the same time, except for studies that only use past data.
  • You must not have received any approved or experimental cancer treatment within 14 days before starting the study drug.
  • You are excluded if you have type I leptomeningeal disease (LMD), a condition where cancer spreads to the thin membranes covering the brain and spinal cord, as defined by specialist criteria.
  • If you have had another invasive cancer (a cancer that spreads into tissues) within the past 5 years, you cannot join, except for skin cancers like basal cell or squamous cell carcinoma that were fully treated, or early‑stage cervical cancer that has not invaded deeper tissue.
  • You cannot participate if you are allergic or have a strong reaction to the study’s diagnostic drug or any of its ingredients.
  • You must not have had a major surgery or a serious injury that required hospital care within 14 days before the first dose, and you should not be expected to need such surgery during the study.
  • Pregnant or breastfeeding women, or anyone not willing to use very effective birth control methods as described in the study, are not eligible.
  • You should not have received a live or weakened (attenuated) vaccine within 30 days before the first study dose.
  • You are excluded if you have an active or uncontrolled infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). Past infections that have resolved are allowed, and HCV antibody‑positive people are allowed only if a test called PCR shows no active virus.
  • You cannot join if you have a known human immunodeficiency virus (HIV) infection that is not well controlled (meaning the virus is not kept at low levels by treatment).
  • Any other active infection that is not under control at the time you enroll will disqualify you.
  • If you have a history of uncontrolled seizures, other serious brain or nervous system disorders, or a severe psychiatric condition that could affect your ability to follow the study plan or be safe, you cannot take part.
  • Known substance abuse (such as misuse of drugs or alcohol) or any other serious and uncontrolled medical problem that the doctor believes makes participation unsafe will exclude you.
  • Any serious medical condition or abnormal lab test result that the doctor thinks makes it unsafe for you to stay in the study will be a reason to exclude you.
  • If the doctor believes you are unable or unwilling to follow the study requirements, you will not be allowed to participate.
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Investigated drugs

  • NETSPOT

    is a special medicine used in PET/CT scans to look for specific receptors on brain tumor cells. It is given through a vein as an injection and helps doctors see whether the tumors have the target that could respond to later treatment. By highlighting these receptors on the scan, NETSPOT helps decide if a patient is eligible for the therapeutic part of the study.

  • Locametz

    is a therapeutic radiopharmaceutical that delivers a small amount of radiation directly to tumor cells in the brain. It is also given by injection into a vein and works by attaching to the same receptors that NETSPOT identifies. Once attached, it releases radiation that can kill the cancer cells, allowing doctors to measure how well the tumor responds to this targeted therapy.

What is already known about the treatment

  • DOTATATE

    DOTATATE is given as an intravenous injection from a kit that is mixed to create a radioactive solution for PET scans. It is an approved radiopharmaceutical used worldwide to image tumors that have somatostatin receptors, especially neuroendocrine tumors, and it is well described in medical literature. The molecule works by attaching to somatostatin receptors on cancer cells, allowing the attached radioactive tag to show the tumor’s location on the scan. It belongs to the class of somatostatin‑analog radiotracers.

  • GOZETOTIDE

    GOZETOTIDE is supplied as a ready‑to‑use solution for intravenous injection that delivers a small amount of radioactivity for PET imaging. It is an approved radiopharmaceutical that targets the PSMA protein and is commonly used to locate prostate cancer spread, with growing evidence for use in other solid tumors. The drug binds to PSMA on the surface of cancer cells, and the attached radioactive element lets doctors see where the tumors are on the scan. It is classified as a PSMA‑targeted radioligand used for diagnostic imaging.

Investigated diseases

  • Small cell lung cancer

    A fast‑growing cancer that begins in the central airways of the lungs. It forms small cells that multiply rapidly and often spread early to nearby lymph nodes, the brain, bones, and other organs. The disease can progress quickly, leading to the formation of new tumor sites in distant parts of the body.

  • HER2‑positive breast cancer

    A form of breast cancer in which tumor cells produce excess HER2 protein, driving rapid cell growth. These tumors can enlarge within the breast and may extend into surrounding tissue. Over time they can enter the lymphatic system and travel to other organs such as the liver, lungs, or bones.

  • Triple‑negative breast cancer

    A breast cancer that lacks estrogen, progesterone, and HER2 receptors, making it a distinct biological subtype. It often appears as a high‑grade tumor that grows quickly and can invade surrounding tissue. The cancer can spread through the lymph nodes and reach distant sites like the lungs, brain, and liver.

  • Solid tumors

    Abnormal masses of tissue that develop in organs or structures other than the blood or lymphatic fluid. They can increase in size, press on nearby organs, and infiltrate surrounding tissues. As they grow, they may break away cells that travel through the bloodstream or lymphatic system to form new growths in other parts of the body.

Trial detailsLast updated 11 Nov 2026
Age18+ yearsPhasePhase IITrial ID2025-523824-39-01Protocol codeMedOPP0838Estimated enrolment20 patientsSponsorMedica Scientia Innovation Research S.L.

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