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Not yet recruiting NCT06646783

Phase IIT Trial of SNA014

Early Phase I Interventional Adenocarcinoma of the Stomach Adenocarcinoma of GE Junction Pancreatic Cancer Stage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: [68Ga]Ga-NODAGA-SNA014.
Who it may be relevant to
Registry conditions: Adenocarcinoma of the Stomach, Adenocarcinoma of GE Junction, Pancreatic Cancer Stage. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

Interventions

  • Drug [68Ga]Ga-NODAGA-SNA014
    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 physi

Primary outcome measures

  • Biological distribution characteristics [Time frame: 1week]
  • Safety tolerance characteristics [Time frame: hrough study completion, an average of 1 year]
Secondary outcome measures (1)
  • Metabolic Dynamics Evaluation and Radiation Dose [Time frame: 1 day]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • The First Affiliated Hospital of Soochow University — Jiangsu

Identifiers

NCT: NCT06646783 · [68Ga]Ga-NODAGA-SNA014

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗