The aim of this study is to establish and optimize the target-specific PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in digestive system malignant tumors will be evaluated.
Aged 18-75 years old and of either sex；
Histologically confirmed diagnosis of digestive system carcinoma or suspected digestive system carcinoma by diagnostic imaging;
Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.
Pregnancy；
Severe hepatic and renal insufficiency;
History of serious surgery in the last month;
Allergic to antibody or single-domain antibody radiopharmaceuticals.
Single group
[68Ga]Ga-DOTA-H2D3
DrugEnrolled patients (especially those with gastric cancer) will receive 0.05-0.1 mCi/kg of a HER2-targeted probe (\[68Ga\]Ga-DOTA-H2D3). ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-DOTA-H2D3 injection.
[18F]F-RESCA-RB14
DrugEnrolled patients (especially those with gastric cancer) will receive 0.05-0.1 mCi/kg of a HER2-targeted probe (\[18F\]F-RESCA-RB14). ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-RB14 injection.
[68Ga]Ga-NOTA-T4
DrugEnrolled patients (especially those with gastric cancer/pancreatic cancer) will receive 0.05-0.1 mCi/kg of a Trop2-targeted probe (\[68Ga\]Ga-NOTA-T4). ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-T4 injection.
[18F]F-RESCA-T4
DrugEnrolled patients (especially those with gastric cancer/pancreatic cancer) will receive 0.05-0.1 mCi/kg of a Trop2-targeted probe (\[18F\]F-RESCA-T4). ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-T4 injection.
[68Ga]Ga-NOTA-G5
DrugEnrolled patients (especially those with hepatocellular carcinoma) will receive 0.05-0.1 mCi/kg of a GPC3-targeted probe (\[68Ga\]Ga-NOTA-G5). ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-G5 injection.
[18F]F-RESCA-G5
DrugEnrolled patients (especially those with hepatocellular carcinoma) will receive 0.05-0.1 mCi/kg of a GPC3-targeted probe (\[18F\]F-RESCA-G5). ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-G5 injection.
[68Ga]Ga-NOTA-WWH347
DrugEnrolled patients (especially those with colorectal cancer) will receive 0.05-0.1 mCi/kg of a GPA33-targeted probe (\[68Ga\]Ga-NOTA-WWH347). ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-WWH347 injection.
[18F]F-RESCA-WWH347
DrugEnrolled patients (especially those with colorectal cancer) will receive 0.05-0.1 mCi/kg of a GPA33-targeted probe (\[18F\]F-RESCA-WWH347). ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-WWH347 injection.
[68Ga]Ga-NOTA-RND20
DrugEnrolled patients will receive 0.05-0.1 mCi/kg of a Nectin-4-targeted probe (\[68Ga\]Ga-NOTA-RND20). ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-RND20 injection.
[18F]F-RESCA-RND20
DrugEnrolled patients will receive 0.05-0.1 mCi/kg of a Nectin-4-targeted probe (\[18F\]F-RESCA-RND20). ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-RND20 injection.
Biodistribution
Measurement of the overall biodistribution of above tracers in normal tissues and organs.
Standardized uptake value (SUV)
Standardized uptake value (SUV) of above tracers in the included subjects' primary and/or metastatic lesions.
Radiation dosimetry
Measurement of absorbed radiation doses (Gy/MBq) to tissues/organs, tumor(s), and whole body (Sv/MBq). Dynamic imaging within one hour will be acquired for the purpose.
Diagnostic value in patients with digestive system malignancy
Systematic evaluation of these parameters will elucidate the pharmacokinetics, pharmacodynamics and, more importantly, the clinical value of these target-specific tracers in patients with malignancies of the digestive system.
Predictive value of these tracers in the course of combined immunotherapies and targeted therapies
Baseline and follow-up immunoPET imaging in combined immunotherapies and targeted therapies (four to eight cycles) will be investigated in this setting to determine the value of the immunoPET imaging in predicting or evaluating treatment responses.
Target-specific PET/CT in changing clinical decision-making for patients with digestive system malignancy
After analyzing the imaging parameters and diagnostic/predictive value of these target-specific tracers, we will also investigate how clinical use of these tracers changes clinical decision-making for patients with malignant tumors of the digestive system. Joint efforts from nuclear medicine physicians, surgeons, oncologists, and pathologists will draw solid conclusions from the imaging and clinical information.
Click on the lead sponsor to view all of their trials.
