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NCT Number: NCT06646783

Phase IIT Trial of SNA014

68Ga labeled Claudin 18.2 contrast agent combined with PET/CT for gastric or gastroesophageal junction

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Key information

Conditions

Adenocarcinoma of the Stomach Adenocarcinoma of GE Junction Pancreatic Cancer Stage

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

The First Affiliated Hospital of Soochow University

Jiangsu, Province, 215000, China

Location contact

ZhangHua Chief Pharmacist, doctorate

CONTACT

[email protected]

0512-677-80040

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age range of 18 to 75 years old (including boundary values);
  • Individuals with behavioral capacity who voluntarily participate in this clinical study and sign an informed consent form (ICF);
  • Diagnosed G/GEJ adenocarcinoma and pancreatic cancer;
  • Gastroscopy/CT/MRI/PET-CT examination results within the past month (if any);
  • Pathological test results and Claudin18.2 immunohistochemistry results within the past year (if available).

Exclusion criteria

  • Merge patients with other clearly diagnosed malignant tumors:
  • Uncontrolled severe infections or individuals with other serious illnesses;
  • Those with an expected survival period of less than or equal to three months;
  • Pregnant or lactating patients, as well as reproductive age patients who refuse to take appropriate contraceptive measures during this trial;
  • investigators determine that patients who are not suitable to participate in this study;

Treatment and study plan

[68Ga]Ga-NODAGA-SNA014

Drug

Perform whole-body PET/CT scans on the subjects at 30 minutes (± 5 minutes), 60 minutes (± 10 minutes), 120 minutes (± 20 minutes), and 240 minutes (± 30 minutes) after administration. Among them, PET scanning can be performed on 1-2 subjects in a certain dose group or each dose group for 30-60 minutes. Among the four CT scans, one CT scan is a conventional low-dose CT scan (120mA), and the remaining three are extremely low-dose CT scans (10-20mA). The main researchers and nuclear medicine physicians can decide whether to change the subsequent image acquisition time and duration of the subjects based on the image information obtained from the enrolled subjects.

Primary outcomes

  1. Biological distribution characteristics

    Time frame: 1week

    Evaluate the biological distribution characteristics of important organs in the subjects.

    • Draw the Volume of Interest (VOI) of the subject's vital organs and calculate the Percentage of Injected Activity (IA) of the vital organs
    • Using PMOD software, manually draw regions of interest (VOI) on PET/CT images of the liver, spleen, normal stomach, heart, bone marrow, kidneys, and other areas to obtain the cumulative radioactive activity of these regions. Divide the cumulative radioactive activity by the injection dose to obtain the percentage of injection activity (% IA).

  2. Safety tolerance characteristics

    Time frame: hrough study completion, an average of 1 year

    AE/SAE/SUSAR

Secondary outcomes

  1. Metabolic Dynamics Evaluation and Radiation Dose

    Time frame: 1 day

    Detect the radiation dose of whole blood and serum of the subjects, and calculate the absorbed dose of important organs

Other outcomes

  1. Exploring the targeting ability of CLDN18.2

    Time frame: 1month

    Correlation analysis between PET/CT imaging features of target lesions (SUVmax, SUV mean, target to body ratio, etc.) and CLDN18.2IHC expression level (if any)

Study contacts

Contact information is provided by the study sponsor or research team.

Miao liyan Chief Pharmacist, doctorate

CONTACT

[email protected]

0512-679-72858

Sponsors and collaborators

Lead sponsor

SmartNuclide Biopharma

Industry

Registry information

Official study title

Clinical Study of 68GA-labeled Claudin 18.2 Developer Combined with PET/CT for Imaging of Gastric or Gastroesophageal Junction Adenocarcinoma and Pancreatic Cancer

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 17, 2024
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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