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Satoreotide Trizoxetan Gallium (Ga68)

This article discusses the ongoing clinical trials of Satoreotide Trizoxetan Gallium (Ga68), also known as 68Ga-SATO, in pediatric patients with neuroblastoma. The study aims to assess the safety and effectiveness of this new imaging agent compared to current diagnostic methods. We’ll explore the trial’s objectives, eligibility criteria, and potential benefits for children with this rare cancer.

Table of Contents

What is SATOREOTIDE TRIZOXETAN GALLIUM (GA68)?

SATOREOTIDE TRIZOXETAN GALLIUM (GA68), also known as 68Ga-SATO, is a diagnostic drug being studied for use in children with neuroblastoma. Neuroblastoma is a type of cancer that often affects young children and typically starts in the early nerve cells of the body.[1]

This drug is also known by other names, including:[1]

  • SATOREOTIDE TRIZOXETAN GALLIUM GA-68
  • OPS-202 GA-68
  • 68Ga-SSO120

Purpose of the Study

The main goal of the study is to check if 68Ga-SATO is safe and well-tolerated by children with neuroblastoma. Researchers want to see if it can be used as a new way to detect and monitor this type of cancer.[1]

How Does It Work?

68Ga-SATO is given as an intravenous injection, which means it’s put directly into a vein. Once in the body, it helps create detailed images of the inside of the body using a special type of scan called PET/CT (Positron Emission Tomography/Computed Tomography).[1]

These images can show where neuroblastoma tumors are in the body. This information is crucial for doctors to diagnose the disease and plan the best treatment.

Potential Benefits

The study aims to compare 68Ga-SATO PET/CT imaging with current methods used to detect neuroblastoma. These include:[1]

  • M123IBG scintigraphy: A type of scan currently used to detect neuroblastoma
  • Whole body MRI: Another imaging technique that can show detailed pictures of the body

If 68Ga-SATO proves to be effective, it could offer several advantages:

  1. More accurate detection of tumors
  2. Potentially faster imaging procedure
  3. Possibly lower radiation exposure for patients

Safety Considerations

The study is designed to carefully monitor the safety of 68Ga-SATO. Researchers will be looking for any side effects or reactions that might occur after the injection. They will use a standardized system called CTCAE v5.0 (Common Terminology Criteria for Adverse Events) to record and grade any side effects.[1]

Who Can Participate?

The study is open to children who either:[1]

  • Are suspected to have neuroblastoma and are getting their first M123IBG scan
  • Have known neuroblastoma and are getting a follow-up M123IBG scan

However, some children cannot participate if they have:

  • Severe auto-immune diseases
  • Used certain medications recently, such as long-acting somatostatin analogs or diuretics
  • Are pregnant (for older participants)

What Does the Procedure Involve?

If a child participates in the study, here’s what they can expect:[1]

  1. They will receive an injection of 68Ga-SATO through a vein.
  2. They will then have a PET/CT scan, which takes detailed pictures of the inside of their body.
  3. For some patients, multiple scans might be taken over time to calculate how the drug moves through the body.
  4. The results will be compared with their regular M123IBG scan and MRI (if available).

The researchers will also keep track of how long the entire procedure takes, from preparation to finishing the scan.

Aspect Details
Drug Name Satoreotide Trizoxetan Gallium (Ga68) / 68Ga-SATO
Trial Category Exploratory, safety, non-randomized, open-label, comparative study
Main Objective Assess short-term safety and tolerability of 68Ga-SATO in pediatric neuroblastoma patients
Secondary Objectives Compare 68Ga-SATO PET/CT to M123IBG scintigraphy and whole-body MRI; Calculate radiation absorbed dose; Evaluate procedure time
Eligibility Pediatric patients with suspected or known neuroblastoma referred for M123IBG imaging
Administration Intravenous injection
Primary Endpoint Short-term safety and tolerability assessment using CTCAE v5.0
Therapeutic Areas Diagnostic Techniques; Neoplasms

FAQ

  • What is the purpose of the 68Ga-SATO clinical trial? The main purpose of the trial is to assess the short-term safety and tolerability of 68Ga-SATO in pediatric patients with neuroblastoma. It also aims to compare 68Ga-SATO PET/CT imaging to current standard methods like M123IBG scintigraphy and whole-body MRI in terms of detecting cancer lesions.
  • Who is eligible to participate in this trial? The trial is open to pediatric patients with a clinical suspicion of neuroblastoma who are referred for their first M123IBG imaging, as well as patients with known neuroblastoma referred for follow-up imaging. Written informed consent from a legal representative and assent from the patient (when applicable) are required.
  • Are there any exclusion criteria for the trial? Yes, patients with pre-existing severe auto-immune diseases, those who have used long-acting somatostatin analogs within 21 days before the planned 68Ga-SATO infusion, or those who have used diuretics within 24 hours before the infusion are excluded. Pregnant patients are also not eligible.
  • How is 68Ga-SATO administered in the trial? 68Ga-SATO is administered as a solution for injection through intravenous (IV) route. The exact dosage and administration details are not provided in the given information.
  • What are the potential benefits of using 68Ga-SATO for neuroblastoma imaging? 68Ga-SATO PET/CT imaging may potentially offer improved lesion detection compared to current standard methods. The trial also aims to evaluate the procedure time for 68Ga-SATO preparation and acquisition, which could lead to more efficient diagnostic processes for pediatric neuroblastoma patients.

Ongoing Clinical Trials on Satoreotide Trizoxetan Gallium (Ga68)

  • Study on the Safety of 68Ga-SATO and Iodine (123I) Iobenguane in Children with Neuroblastoma

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

Glossary

  • Neuroblastoma (NBL): A type of cancer that develops from immature nerve cells, most commonly affecting children under the age of 5. It usually starts in the adrenal glands but can also develop in other areas of the abdomen, chest, neck, or spine.
  • 68Ga-SATO: A radioactive imaging agent containing Satoreotide Trizoxetan labeled with Gallium-68, used in PET/CT scans to detect neuroblastoma lesions.
  • PET/CT: Positron Emission Tomography/Computed Tomography, an imaging technique that combines PET and CT scans to provide detailed pictures of both the structure and function of tissues and organs in the body.
  • M123IBG scintigraphy: A nuclear medicine imaging technique using radioactive iodine-123 labeled metaiodobenzylguanidine to detect neuroblastoma and other neuroendocrine tumors.
  • CTCAE: Common Terminology Criteria for Adverse Events, a set of criteria used to evaluate and grade the severity of side effects in cancer therapy and clinical trials.
  • Somatostatin analogs: Drugs that mimic the action of somatostatin, a natural hormone that regulates various endocrine functions. These are sometimes used in the treatment of certain cancers and endocrine disorders.
  • Diuretics: Medications that increase the production of urine, often used to treat conditions like high blood pressure or fluid retention.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-of-68ga-sato-and-iodine-123i-iobenguane-in-children-with-neuroblastoma/