Appendix Cancer, Bile Duct Carcinoma, Colon Cancer, Digestive Cancer, Digestive System Cancer, Digestive System Carcinoma, Digestive System Neoplasm, Esophagus Cancer, Gallbladder Carcinoma, Liver Cancer, Malignancy, Pancreatic Cancer, Rectum Cancer, Small Intestine Cancer, Stomach Cancer
Conditions
Keywords
human epidermal growth factor receptor 2 (HER2), Trophoblast cell surface antigen 2 (TROP2), Glypican-3 (GPC3), Glycoprotein A33 (gpA33), Nectin cell adhesion molecule-4 (Nectin-4)
Brief summary
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.
Detailed description
Enrolled patients will undergo whole-body PET/CT scans at 1 hours after tracer injection(0.05-0.1 mCi/kg). Uptake of above imaging agents in tumor and normal organs/tissues will be scored visually and quantitatively. Tumor uptake will be quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy will be calculated to evaluate the diagnostic efficacy. The correlation between lesion uptake and protein expression level determined by immunohistochemistry staining will be further analyzed. The exploration endpoint will be the imaging feasibility and preliminary diagnostic value of the above tracers.
Interventions
DRUG[68Ga]Ga-DOTA-H2D3
Enrolled 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.
Enrolled 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.
DRUG[68Ga]Ga-NOTA-T4
Enrolled 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.
DRUG[18F]F-RESCA-T4
Enrolled 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.
DRUG[68Ga]Ga-NOTA-G5
Enrolled 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.
DRUG[18F]F-RESCA-G5
Enrolled 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.
DRUG[68Ga]Ga-NOTA-WWH347
Enrolled 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.
DRUG[18F]F-RESCA-WWH347
Enrolled 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.
DRUG[68Ga]Ga-NOTA-RND20
Enrolled 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.
DRUG[18F]F-RESCA-RND20
Enrolled 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.
Sponsors
RenJi Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18-75 years old and of either sex； 2. Histologically confirmed diagnosis of digestive system carcinoma or suspected digestive system carcinoma by diagnostic imaging; 3. Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.
Exclusion criteria
1. Pregnancy； 2. Severe hepatic and renal insufficiency; 3. History of serious surgery in the last month; 4. Allergic to antibody or single-domain antibody radiopharmaceuticals.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standardized uptake value (SUV) | 1 day from injection of the tracers | Standardized uptake value (SUV) of above tracers in the included subjects' primary and/or metastatic lesions. |
| Diagnostic value in patients with digestive system malignancy | 30 days | 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. |
| The correlation between the expression of specific target and tracer uptake value | 60 days | The Standardized uptake value (SUV) will be calculated, and the correlation between pathological results and tumor uptake of these tracers will be analyzed. |
| Biodistribution | 1 day from injection of the tracers | Measurement of the overall biodistribution of above tracers in normal tissues and organs. |
| Radiation dosimetry | 1 day from injection of the tracers | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target-specific PET/CT in changing clinical decision-making for patients with digestive system malignancy | 3-6 months | 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. |
| Predictive value of these tracers in the course of combined immunotherapies and targeted therapies | 3-6 months | 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. |
Countries
China
Contacts
Primary ContactWeijun Wei, Ph.D. & M.D.
Backup ContactShuxian An, Ph.D. & M.D.
Outcome results
None listed