Clinical Study of CLDN18.2 PET/CT for Noninvasive Diagnosis of Gastric and Pancreatic Cancer

February 15, 2024 updated by: YiHui Guan
In this study, we will investigate the diagnostic efficacy and safety of [18F]F-H3RESCA-3A12 and [68Ga]Ga-NOTA-3A12 in metastatic gastric and pancreatic cancers, and evaluate the sensitivity and specificity of the use of [18F]F-H3RESCA-3A12 and [68Ga]Ga-NOTA-3A12 for diagnosing metastatic gastric and pancreatic cancers . This study will provide a new method for the noninvasive target-specific diagnosis of gastric and pancreatic cancer, and provide intuitive and clear imaging basis for clinical diagnosis, differential diagnosis and treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200235
        • Recruiting
        • PET Center, Huashan Hospital, Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • (1) Age between 18 and 65 years old, gender is not limited. (2) Patients with gastric or pancreatic cancer confirmed by puncture or surgical pathology.

    (3) Written informed consent signed by the subject or his/her legal guardian or caregiver.

    (4) Willingness and ability to cooperate with all programs of this study.

Exclusion Criteria:

- (1) Severe hepatic or renal insufficiency; (2) Targeted therapy before radiotherapy or PET/CT scan. (3)Renal function: serum creatinine less than or equal to the upper limit of the normal range;Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range.

(4) History of serious surgery in the last month. (5) Those who have participated in other clinical trials during the same period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients with gastric cancer
Subjects were recruited from the Department of General Surgery, Huashan Hospital, Fudan University, Shanghai, China.
Radiation: [18F]F-H3RESCA-3A12及[68Ga]Ga-NOTA-3A12
The dose of [18F]RCCB6 was calculated based on the patient's body weight to be 3.7 MBq [0.1 MCi]/kg, and the method of administration was intravenous push, with a single visualization administered once.
Experimental: patients with pancreatic cancer
Subjects were recruited from the Department of General Surgery, Huashan Hospital, Fudan University, Shanghai, China.
Radiation: [18F]F-H3RESCA-3A12及[68Ga]Ga-NOTA-3A12
The dose of [18F]RCCB6 was calculated based on the patient's body weight to be 3.7 MBq [0.1 MCi]/kg, and the method of administration was intravenous push, with a single visualization administered once.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the sensitivity and specificity of using [18F]F-H3RESCA-3A12 and [68Ga]Ga-NOTA-3A12 for the diagnosis of metastatic gastric and pancreatic cancer
Time Frame: 90mins from time of injection
In this study, we will first investigate the safety and feasibility of [18F]F-H3RESCA-3A12 and [68Ga]Ga-NOTA-3A12 in metastatic gastric and pancreatic cancers. The secondary goal of the clinical trial is to preliminary assess the sensitivity and specificity of using [18F]F-H3RESCA-3A12 or [68Ga]Ga-NOTA-3A12 PET/CT imaging for the diagnosis of metastatic gastric or pancreatic cancers.
90mins from time of injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

YiHui Guan

Investigators

  • Principal Investigator: Fang Xie, PhD, Huashan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 3, 2024

First Submitted That Met QC Criteria

January 3, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2023-1015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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