Phase IIT Trial of SNA014

NCT ID: NCT06646783

Last Updated: 2024-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-20

Study Completion Date

2025-11-20

Brief Summary

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

Detailed Description

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Conditions

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Adenocarcinoma of the Stomach Adenocarcinoma of GE Junction Pancreatic Cancer Stage

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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dose escalation

subgroups mass does escalation

Group Type EXPERIMENTAL

[68Ga]Ga-NODAGA-SNA014

Intervention Type 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.

Interventions

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[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 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.

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SmartNuclide Biopharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital of Soochow University

Jiangsu, Province, China

Site Status

Countries

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China

Central Contacts

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Miao liyan Chief Pharmacist, doctorate

Role: CONTACT

0512-679-72858

Facility Contacts

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ZhangHua Chief Pharmacist, doctorate

Role: primary

0512-677-80040

Other Identifiers

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[68Ga]Ga-NODAGA-SNA014

Identifier Type: -

Identifier Source: org_study_id

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