Igestive System Neoplasms, Pancreatic Neoplasms, Positron Emission Tomography
Conditions
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.
Interventions
RADIATION[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.
Sponsors
YiHui Guan
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactYihui Guan, MD
Outcome results
None listed