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

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

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Positron Emission Tomography Pancreatic Neoplasms Igestive System Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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patients with gastric cancer

Subjects were recruited from the Department of General Surgery, Huashan Hospital, Fudan University, Shanghai, China.

Group Type EXPERIMENTAL

[18F]F-H3RESCA-3A12及[68Ga]Ga-NOTA-3A12

Intervention Type RADIATION

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.

patients with pancreatic cancer

Subjects were recruited from the Department of General Surgery, Huashan Hospital, Fudan University, Shanghai, China.

Group Type EXPERIMENTAL

[18F]F-H3RESCA-3A12及[68Ga]Ga-NOTA-3A12

Intervention Type RADIATION

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.

Interventions

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[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.

Intervention Type RADIATION

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No