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

YiHui Guan

Status: Enrolling

Conditions: Positron Emission Tomography; Pancreatic Neoplasms; Igestive System Neoplasms

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06203613

KY2023-1015

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

patients with gastric cancer

Experimental group

Description:

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

Treatment:

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

patients with pancreatic cancer

Experimental group

Description:

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

Treatment:

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