99mTc Labeled FAP Targeted Molecular Probe in Early Diagnosis of Tumors

NCT ID: NCT06438705

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2026-05-31

Brief Summary

At present, radiopharmaceuticals targeting FAP have been developed for the diagnosis and treatment of various tumors. Considering the problems of fast tumor tissue clearance and short retention time in small molecule FAP inhibitors based on quinoline rings, this project optimized their ligands and developed a new FAP targeted technetium labeled molecular imaging probe for SPECT/CT imaging research to evaluate its safety in clinical application and its effectiveness in tumor diagnosis.

Conditions

Head and Neck Tumor; Lung Cancer; Pancreatic Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

SPECT-CT imaging

The subjects were intravenously injected with 99mTc labeled FAPI imaging agent, and drank 300-500ml of water after administration. SPECT-CT imaging was performed 60 minutes later

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Voluntary subjects, patients or their legal representatives sign informed consent;
• Volunteers are of any gender and aged between 18 and 75 years old, including the cut-off value;
• Other imaging methods found tumor occupying;
• Patients with pre-treatment tumors for whom surgery or biopsy may be performed to obtain final pathological results.
• Kidney glomerular filtration rate(GFR)>50 ml/min, effective renal plasma flow(ERPF)>280 ml/min, platelet count (PLT) >75 000/μL, white blood cell (WBC) >3000/μL, alanine aminotransferase ALT, aspartate aminotransferase AST less than 3 times the normal value.

Exclusion Criteria

• People who have a history of allergy to similar drugs , allergic constitution or are currently suffering from allergic diseases;
• Is conducting clinical research on other drugs, or has participated in clinical research on any drugs (excluding vitamins and minerals);
• Have other clinical problems that are difficult to control (such as hepatitis C virus infection or active hepatitis B, or other serious chronic infections and serious mental, neurological, cardiovascular, respiratory and other diseases);
• Obvious abnormal liver and kidney function, GFR less than 50 ml/min;
• Tumor load is greater than 50%, or there is obvious spinal cord compression;
• The expected survival period is less than half a year; Chemotherapy was performed within 6 months.
• Have severe acute concomitant diseases or serious refractory mental disorders;
• Pregnant and lactating women (where pregnancy is defined as a positive urine pregnancy study);
• Patients whose physical condition is not suitable for radiological examination;
• Other situations deemed inappropriate by the investigator to participate in the trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Feng Wang

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nanjing First Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Feng Wang, Ph.D.

Role: primary

fengwangcn@hotmail.com

86-025-52271455

Other Identifiers

KY20240419-08

Identifier Type: -

Identifier Source: org_study_id