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

Not Applicable

Recruiting

• Conditions: Positron Emission Tomography; Igestive System Neoplasms; Pancreatic Neoplasms
• Interventions: Radiation: [18F]F-H3RESCA-3A12及[68Ga]Ga-NOTA-3A12

• Registration Number: NCT06203613
• Lead Sponsor: YiHui Guan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-01
• Study First Submitted: 2024-01-03
• Study First Submitted QC: 2024-01-03
• Study First Posted: 2024-01-12
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-16
• Primary Completion: 2024-09-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients with gastric cancer	[18F]F-H3RESCA-3A12及[68Ga]Ga-NOTA-3A12	Subjects were recruited from the Department of General Surgery, Huashan Hospital, Fudan University, Shanghai, China.
patients with pancreatic cancer	[18F]F-H3RESCA-3A12及[68Ga]Ga-NOTA-3A12	Subjects were recruited from the Department of General Surgery, Huashan Hospital, Fudan University, Shanghai, China.

Primary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

PET Center, Huashan Hospital, Fudan University; 🇨🇳 Shanghai, China