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

Pancreatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06203613
• Other study ID #: KY2023-1015
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2024
• Source: Huashan Hospital
• Contact: Yihui Guan, MD
• Phone: 13764308300
• Email: guanyihui[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Pancreatic Neoplasms
• Positron Emission Tomography

Intervention

Radiation:
• [18F]F-H3RESCA-3A12?[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.

Locations

Country	Name	City	State
China	PET Center, Huashan Hospital, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
YiHui Guan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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