Research on Early Diagnosis and Clinical Transformation of Nuclide Probe Based on Bioorthogonal-gastric Cancer Mucin Target Visualization

NCT06429891 | Recruiting

• 1 other identifier: 2024KT68
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Standardized uptake value (SUV)

  The uptake of the tracer (89Zr-16A) in solid tumor lesions or suspected tumor lesions by measuring SUV on PET/CT.

  2 years

Study Arms (1)

89Zr-16A

EXPERIMENTAL

All study participants will be allocated to this arm (single-arm study). Study participants will undergo 89Zr-16A PET/CT scans.

Drug: 18F-FDG

Interventions

18F-FDG DRUG

All study participants will undergo one 18F-FDG PET/CT scan.

89Zr-16A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 years old; ECOG 0 or 1;
• Patients with solid tumor confirmed by histopathology;
• Patients with imaging confirmed measurable lesions;
• life expectancy \>=12 weeks.

You may not qualify if:

• Significant hepatic or renal dysfunction;
• ls pregnant or ready to pregnant;
• Cannot keep their states for half an hour;
• Refusal to join the clinical study;
• Suffering from claustrophobia or other mental diseases；
• Any other situation that researchers think it is not suitable to participate in the experiment.

Sponsors & Collaborators

• Hua Zhu: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Interventions

Fluorodeoxyglucose F18

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Hua Zhu

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hua Zhu

CONTACT

+861088196495; zhuhuabch@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: August 20, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

CN (1)