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Trial Title:
Research on Early Diagnosis and Clinical Transformation of Nuclide Probe Based on Bioorthogonal-gastric Cancer Mucin Target Visualization
NCT ID:
NCT06429891
Condition:
Solid Tumor
Conditions: Official terms:
Stomach Neoplasms
Fluorodeoxyglucose F18
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
18F-FDG
Description:
All study participants will undergo one 18F-FDG PET/CT scan.
Arm group label:
89Zr-16A
Summary:
The symptoms of early gastric cancer are extremely insidious and most patients are
identified as advanced at the time of initial diagnosis. Starting from the clinical
needs, this project selects solid tumors and pathogenic glycoprotein synthesis of key
glycopeptide antigen determinant mucin (MUC) family of multiple molecules as the research
object. Based on the digestive system tumor research cohort established in the early
stage, this project intends to verify the tumor microenvironment characteristics of the
MUC family and gastric cancer treatment resistance through immunohistochemistry, COSMC
gene sequencing and other technologies, and screen key MUC family proteins. Based on the
discovery of differential recognition of COSMC deficient cells by antibodies,
MUC1-targeted specific monoclonal antibody was developed. Further development of spatial
mucinomics based on laser ablation inductively coupled plasma mass spectrometry
(LA-IPC-MS) and spatial metabolome based on desorption electrospray mass spectrometry
(DESI-MS) to analyze the structure and immunosuppressive mechanism of key gastric cancer
glycoprotein MUC. After obtaining key targeted antibodies, with the help of biological
orthogonal and click chemistry technology, the original clinical translational research
based on mucin targeting was carried out, and a high-affinity nuclide conjugate drug
(RDC) with "triple binding" of gastric cancer mucin was constructed and clinical
translational research was carried out, which provided new ideas for the accurate
diagnosis and treatment of gastric cancer in the early stage.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Aged ≥18 years old; ECOG 0 or 1;
2. Patients with solid tumor confirmed by histopathology;
3. Patients with imaging confirmed measurable lesions;
4. life expectancy >=12 weeks.
Exclusion Criteria:
1. Significant hepatic or renal dysfunction;
2. ls pregnant or ready to pregnant;
3. Cannot keep their states for half an hour;
4. Refusal to join the clinical study;
5. Suffering from claustrophobia or other mental diseases；
6. Any other situation that researchers think it is not suitable to participate in the
experiment.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Hua Zhu, Dr.
Phone:
+861088196495
Email:
zhuhuananjing@163.com
Start date:
August 20, 2024
Completion date:
December 2026
Lead sponsor:
Agency:
Hua Zhu
Agency class:
Other
Source:
Peking University Cancer Hospital & Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06429891
