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

Lung Cancer Clinical Trial

Official title:

Clinical Application of a Novel 99mTc Labeled Fibroblast Activating Protein (FAP) Targeted Molecular Probe in Early Diagnosis of Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06438705
• Other study ID #: KY20240419-08
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: January 31, 2026

Study information

• Verified date: May 2024
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Head and Neck Tumor
• Lung Cancer
• Pancreatic Cancer

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor uptake	Compare the lesion site with surrounding normal tissue to evaluate whether there is a significant increase in radioactive uptake. Select the lesion in the abnormal area of the image and draw a 3D area of interest (ROI) to obtain the average lesion volume count (T). Calculate the tumor target/non target value (T/NT) statistically	1 hour after administering the probe