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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer; Lung Cancer; Head and Neck Tumor
• Intervention / Treatment: Diagnostic test: SPECT-CT imaging

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Recruiting
      • Nanjing First Hospital
      • Contact: Feng Wang, Ph.D.; Phone Number: 86-025-52271455; Email: fengwangcn@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This study was mainly conducted by SPECT CT imaging, and a total of 20 cases were planned to be enrolled, which were evaluated by 2 attending physicians of nuclear medicine or above according to various measurement data of the subjects

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: May 31, 2024
• First Posted (Actual): June 3, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 7, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: KY20240419-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No