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Trial Title:
Clinical Study of CLDN18.2 PET/CT for Noninvasive Diagnosis of Gastric and Pancreatic Cancer
NCT ID:
NCT06203613
Condition:
Positron Emission Tomography
Pancreatic Neoplasms
Igestive System Neoplasms
Conditions: Official terms:
Neoplasms
Pancreatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
[18F]F-H3RESCA-3A12及[68Ga]Ga-NOTA-3A12
Description:
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.
Arm group label:
patients with gastric cancer
Arm group label:
patients with pancreatic cancer
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
PET Center, Huashan Hospital, Fudan University
Address:
City:
Shanghai
Zip:
200235
Country:
China
Status:
Recruiting
Contact:
Last name:
Yi Hui Guan, MD
Phone:
86-21-64285263
Phone ext:
128
Email:
guanyihui@hotmail.com
Start date:
December 1, 2023
Completion date:
December 1, 2024
Lead sponsor:
Agency:
YiHui Guan
Agency class:
Other
Source:
Huashan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06203613
